Procedures for vascular occlusion

ABSTRACT

A method of reducing blood flow within an aneurysm includes: injecting a contrast agent into a blood vessel including an aneurysm; expanding a stent, from a delivery device, across the aneurysm; and confirming that a stagnated area forms in the aneurysm. The stagnated area can form a crescent shape, a mushroom shape, a hemispherical shape, and/or a flat side. Upon confirming that the stagnated area forms in the aneurysm, the delivery device can be withdrawn from the blood vessel. The stagnated area can include the contrast agent. If the stagnated area does not form in the aneurysm, a second occluding device may be deployed. After withdrawing the delivery device, substantially all of the aneurysm progressively thromboses.

This application is a continuation of U.S. application Ser. No.15/083,529, filed Mar. 29, 2016, which is (i) a continuation of U.S.application Ser. No. 14/791,617, filed Jul. 6, 2015, now U.S. Pat. No.9,408,728, issued Aug. 9, 2016, which is a continuation of U.S.application Ser. No. 13/652,591, filed Oct. 16, 2012, now U.S. Pat. No.9,095,460, issued Aug. 4, 2015, which is a continuation of U.S.application Ser. No. 12/751,997, filed Mar. 31, 2010, now U.S. Pat. No.8,409,269, issued Apr. 2, 2013, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 61/288,525, filed Dec.21, 2009, and (ii) a continuation-in-part of U.S. application Ser. No.14/885,576, filed Oct. 16, 2015, now abandoned, which is a continuationof U.S. application Ser. No. 14/026,510, filed Sep. 13, 2013, now U.S.Pat. No. 9,161,851, issued Oct. 20, 2015, which is a continuation ofU.S. application Ser. No. 12/490,285, filed Jun. 23, 2009, now U.S. Pat.No. 8,556,953, issued Oct. 15, 2013, each of the above applicationsbeing hereby expressly incorporated herein by reference in theirentireties.

BACKGROUND

The present application generally relates to implantable devices for usewithin a patient's body and, more particularly, relates to methods forimplanting occluding devices in a patient's body and monitoring anocclusion.

Lumens in the body can change in size, shape, and/or patency, and suchchanges can present complications or affect associated body functions.For example, the walls of the vasculature, particularly arterial walls,may develop pathological dilatation called an aneurysm. Aneurysms areobserved as a ballooning-out of the wall of an artery. This is a resultof the vessel wall being weakened by disease, injury or a congenitalabnormality. Aneurysms have thin, weak walls and have a tendency torupture and are often caused or made worse by high blood pressure.Aneurysms can be found in different parts of the body; the most commonbeing abdominal aortic aneurysms (AAA) and the brain or cerebralaneurysms. The mere presence of an aneurysm is not alwayslife-threatening, but they can have serious heath consequences such as astroke if one should rupture in the brain. Additionally, a rupturedaneurysm can also result in death.

SUMMARY

At least one aspect of the disclosure provides methods for implanting anoccluding device or devices (e.g., stent or stents) in the body. Theoccluding device can easily conform to the shape of the tortuous vesselsof the vasculature. The occluding device can direct the blood flowwithin a vessel away from an aneurysm. Additionally, such an occludingdevice can allow adequate blood flow to be provided to adjacentstructures such that those structures, whether they are branch vesselsor oxygen demanding tissues, are not deprived of the necessary bloodflow.

In some embodiments, a method of reducing blood flow within an aneurysmcan comprise injecting a contrast agent into a blood vessel comprisingan aneurysm; deploying an occlusion device from a delivery system acrossthe aneurysm; producing an image of the aneurysm including the contrastagent; and withdrawing the delivery device from the vessel afterobserving that the aneurysm has been obstructed by a desired amount.

In some embodiments, a method of reducing blood flow within an aneurysmcan comprise injecting a contrast agent into a blood vessel comprisingan aneurysm; deploying an occlusion device from a delivery device acrossthe aneurysm; producing an image of the aneurysm including the contrastagent; observing a shape formed by the contrast agent after deployingthe occlusion device; and withdrawing the delivery device from thevessel after observing the shape.

In some embodiments, a method of implanting a stent at an aneurysm cancomprise: providing an elongate body comprising a proximal portion, adistal portion, and a lumen extending between the proximal portion andthe distal portion; advancing the elongate body into the patient untilthe distal portion is adjacent to the aneurysm; delivering a stentacross the aneurysm from within the lumen at the distal portion of theelongate body, wherein delivering the stent comprises expanding thestent from a compressed configuration to an expanded configuration witha first location distal to the aneurysm and a second location proximalto the aneurysm; observing stagnation within the aneurysm caused bydelivering the stent across the aneurysm; and withdrawing the elongatebody from the patient with the expanded stent remaining across theaneurysm once the observed partial stagnation produces a persistentshape in the aneurysm.

In some embodiments, a method of reducing blood flow within an aneurysmcan comprise: injecting a contrast agent into a blood vessel comprisingan aneurysm, at least a portion of the contrast agent flowing into theaneurysm; deploying an occlusion device from a delivery device acrossthe aneurysm; stagnating the portion of the contrast agent in theaneurysm; producing an image of the aneurysm including the portion ofthe contrast agent; observing a shape formed by the portion of thecontrast agent in the aneurysm after deploying the occlusion device; andwithdrawing the delivery device from the vessel after observing theshape.

In some embodiments, a method of implanting an occluding device cancomprise implanting a stent at an aneurysm in a blood vessel byproviding an elongate body comprising a proximal portion, a distalportion, and a lumen extending between the proximal portion and thedistal portion; inserting the distal portion in a blood vesselcomprising an aneurysm; advancing the distal portion within the bloodvessel until the distal portion is at the aneurysm; advancing, relativeto the elongate body and within the lumen of the elongate body, a stentin a compressed configuration; expanding the stent within the vessel,the expanded stent extending from a first location distal to theaneurysm to a second location proximal to the aneurysm; and followingthe expanding the stent and upon determining whether fluid flow in theaneurysm has stagnated by at least about 50% of an area or a volume ofthe aneurysm observed on an image, withdrawing the elongate body fromthe vessel.

In some embodiments, a method of at least partially obstructing ananeurysm can comprise advancing a delivery device within a blood vesseluntil a distal portion of the delivery device is adjacent the aneurysm;expanding a stent across the aneurysm; imaging the aneurysm; determininga degree of obstruction of the aneurysm after expanding the stent; andafter determining that a body of the aneurysm has been obstructed atleast about 50%, withdrawing the delivery device from the vessel.

In some embodiments, a method of treating an aneurysm can compriseadvancing a delivery device within a blood vessel comprising an aneurysmuntil a distal portion of the device is adjacent the aneurysm; expandinga first stent within the vessel, the expanded first stent extending froma first side of the aneurysm to a second side of the aneurysm; andwithdrawing the delivery device from the vessel upon determining thatthe aneurysm is between about 50% and about 100% occluded.

In some embodiments, a method of reducing blood flow within an aneurysmcan comprise injecting a contrast agent into a blood vessel comprisingan aneurysm; deploying an occlusion device from a delivery system acrossthe aneurysm; producing an image of the aneurysm including the contrastagent; and withdrawing the delivery device from the vessel afterobserving that the aneurysm has been obstructed by a desired amount.

In some embodiments, a method of reducing blood flow within an aneurysmcan comprise injecting a contrast agent into a blood vessel comprisingan aneurysm; deploying an occlusion device from a delivery device acrossthe aneurysm; producing an image of the aneurysm including the contrastagent; observing a shape formed by the contrast agent after deployingthe occlusion device; and withdrawing the delivery device from thevessel after observing the shape.

In some embodiments, a method of implanting a stent at an aneurysm cancomprise providing an elongate body comprising a proximal portion, adistal portion, and a lumen extending between the proximal portion andthe distal portion; advancing the elongate body into the patient untilthe distal portion is adjacent to the aneurysm; delivering a porousstent across the aneurysm from within the lumen at the distal portion ofthe elongate body, wherein delivering the stent comprises expanding thestent from a compressed configuration to an expanded configuration witha first location distal to the aneurysm and a second location proximalto the aneurysm; circulating contrast agent into the aneurysm throughthe stent after the stent is delivered; observing stagnation within theaneurysm caused by delivering the stent across the aneurysm, wherein thestagnation is a partial stagnation indicated by the presence of an areaof stagnation within the aneurysm and contrast agent circulation withinthe aneurysm; and withdrawing the elongate body from the patient withthe expanded stent remaining across the aneurysm once the observedstagnation produces a persistent shape in the aneurysm.

In some embodiments, a method of reducing blood flow within an aneurysmcan comprise injecting a contrast agent into a blood vessel comprisingan aneurysm, at least a portion of the contrast agent flowing into theaneurysm; deploying an occlusion device from a delivery device acrossthe aneurysm; stagnating the portion of the contrast agent in theaneurysm; producing an image of the aneurysm including the portion ofthe contrast agent; observing a shape formed by the portion of thecontrast agent in the aneurysm after deploying the occlusion device; andwithdrawing the delivery device from the vessel after observing theshape.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andembodiments hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the subject technology and are incorporated in andconstitute a part of this specification, illustrate aspects of thedisclosure and together with the description serve to explain theprinciples of the subject technology.

FIG. 1 is an illustration of an aneurysm, branch vessels and blood flowto the aneurysm.

FIGS. 2A and 2B illustrate embodiments of an occluding device to treataneurysms.

FIG. 3 is an illustration of embodiments shown in FIGS. 2A and 2B in acompressed state inside a catheter.

FIG. 4A depicts embodiments of an occluding device for treatinganeurysms.

FIGS. 4B and 4C illustrate cross sections of portions of ribbons thatcan be used to form the occluding device of FIG. 4A.

FIG. 5 shows the occluding device in a compressed state inside acatheter being advanced out of the catheter using a plunger.

FIG. 6 shows the compressed occluding device shown in FIG. 5 deployedoutside the catheter and is in an expanded state.

FIG. 7 shows the deployed occluding device inside the lumen of a vesselspanning the neck of the aneurysm, a bifurcation and branch vessels.

FIG. 8 is a schematic showing the occluding device located in the lumenof a vessel and the change in the direction of the blood flow.

FIG. 9 shows the effect of a bending force on a conventional stentcompared to the occluding device of the present disclosure.

FIG. 10 depicts the flexibility of the occluding device, compared to atraditional stent, by the extent of the deformation for an appliedforce.

FIGS. 11A, 11B, 11C, 11D, 11E, 11F, and 11G show the non-uniform densityof the braid that provides the desired occluding device.

FIG. 12 illustrates the difference in lattice density due to thenon-uniform density of the braiding of the occluding device.

FIG. 13 shows the varying lattice density occluding device covering theneck of an aneurysm.

FIGS. 14 and 15 show embodiments of the vascular occluding device wherethe lattice density is asymmetrical about the longitudinal axis near theaneurysm neck.

FIG. 16 illustrates a bifurcated occluding device according toembodiments of the disclosure in which two occluding devices of lesserdensities are combined to form a single bifurcated device.

FIG. 17 illustrates embodiments of braiding elements of a lattice in anoccluding device.

FIG. 18 illustrates an example of a braiding element of a lattice in anoccluding device.

FIG. 19 illustrates an example of another braiding element of a latticein an occluding device.

FIG. 20 illustrates a braiding element of an occluding device fittedinto a vessel diameter.

FIG. 21 is a cross sectional view of an example of a protective coil.

FIG. 22 illustrates an example of determining ribbon dimensions of anoccluding device in a protective coil or a delivery device.

FIG. 23 illustrates another example of determining ribbon dimensions ofan occluding device in a protective coil or a delivery device.

FIG. 24 illustrates an example of determining a ribbon width based on anumber of ribbons.

FIG. 25 illustrates a relationship between the PPI of the occludingdevice in a vessel versus the PPI of the occluding device in afree-standing state.

FIG. 26 illustrates an example of a maximum ribbon size that fits in aprotective coil.

FIG. 27 is a graph showing the opening sizes of braiding elements in theoccluding device as a function of the PPI of the lattice structure.

FIG. 28 illustrates the in-vessel PPI as a function of the braided PPIof a 32 ribbon occluding device.

FIG. 29 illustrates the percent coverage as a function of the braidedPPI for a 32 ribbon occluding device.

FIG. 30 illustrates the opening sizes of braiding elements in theoccluding device as a function of the braided PPI of the latticestructure for a 32 ribbon occluding device.

FIG. 31 illustrates an example of a lattice density adjusting implementfor adjusting lattice density in an occluding device.

FIG. 32 shows an example of a deployed occluding device inside the lumenof a vessel spanning the neck of aneurysms, a bifurcation and branchvessels.

FIG. 33 illustrates an example of an occluding device in a compressedconfiguration.

FIG. 34 illustrates an example of an occluding device in an expandedconfiguration.

FIG. 35 illustrates an example of an occluding device in a hyperexpandedconfiguration.

FIGS. 36A, 36B and 36C illustrate various examples of relationshipsbetween the length and the diameter of the occluding device.

FIG. 37 illustrates embodiments of the occluding device in treating ananeurysm.

FIG. 38 illustrates an example of an occluding device deployed withinanother occluding device.

FIG. 39 illustrates an example of two occluding devices with anoverlapping portion.

FIG. 40 illustrates a cross sectional view of an example of an occludingdevice deployed within another occluding device.

FIG. 41 illustrates an example of two occluding devices with anoverlapping portion.

FIG. 42 illustrates embodiments of multiple occluding devices intreating an aneurysm.

FIG. 43 is a cross section of an occluding device delivery assembly andoccluding device according to an aspect of the disclosure.

FIG. 44 illustrates a catheter and introducer sheath shown in FIG. 43.

FIG. 45 is a partial cut away view of the introducer sheath of FIG. 44carrying a guidewire assembly loaded with an occluding device.

FIG. 46 is a cross section of the guidewire assembly illustrated in FIG.45.

FIG. 47 is a schematic view of the guidewire assembly of FIG. 46.

FIG. 48 is a second schematic view of the guidewire assembly of FIG. 46.

FIG. 49 illustrates the occluding device and a portion of the guidewireassembly positioned outside the catheter, and how a proximal end of theoccluding device begins to deploy within a vessel.

FIG. 50 illustrates a step in the method of deploying the occludingdevice.

FIG. 51 illustrates the deployment of the occluding device according toan aspect of the disclosure.

FIG. 52 is a schematic view of a guidewire assembly according to anotherembodiment of the disclosure.

FIG. 53 is a schematic view of the deployed occluding device afterhaving been deployed by the guidewire assembly of FIG. 52.

FIG. 54 illustrates an example of an expanded occluding device thatexpands responsive to pressure.

FIG. 55 illustrates the occluding device of FIG. 54 after a negativepressure is applied to the occluding device.

FIG. 56 illustrates an example of release of the distal end of theoccluding device while the proximal end of the occluding device remainsattached to the delivery device.

FIG. 57 illustrates an example of a partially deployed occluding device.

FIG. 58 illustrates another example of a partially deployed occludingdevice.

FIG. 59 illustrates the example of FIG. 58 in which the occluding deviceis repositioned proximally in the blood vessel.

FIG. 60 illustrates an example of an expanded occluding device.

FIG. 61 illustrates the example of FIG. 60 after the occluding device isrepositioned within a blood vessel.

FIG. 62 illustrates an example of the occluding device in a retractedstate.

FIG. 63 illustrates an example of repositioning the occluding devicewhile the occluding device is retracted.

FIG. 64 is a cutaway view of a catheter carrying a guidewire assemblyloaded with a stent according to an embodiment of the disclosure.

FIG. 65 illustrates an example of the catheter positioned at a treatmentsite in a blood vessel.

FIG. 66 illustrates an example of the stent partially deployed in theblood vessel.

FIG. 67 illustrates an example of a balloon inflated in the blood vesselto treat a stenotic region with the partially deployed stent acting as afilter to capture plaque debris from the treatment.

FIG. 68 illustrates an example of the balloon deflated back to adeflated state.

FIG. 69 illustrates an example of the stent fully deployed in the bloodvessel.

FIG. 70 is a cutaway view of the catheter carrying the guidewireassembly loaded with the stent according to another embodiment of thedisclosure.

FIG. 71 is a perspective view of the catheter with a cutting toolaccording to an embodiment of the disclosure.

FIG. 72 illustrates an example of the cutting tool of the catheter beingused to treat a stenotic region in a blood vessel with a partiallydeployed stent acting as a filter to capture plaque debris from thetreatment.

FIG. 73 is a cutaway view of a catheter carrying a guidewire assemblyand a cutting tool according to embodiments disclosed herein.

FIG. 74 illustrates an example of the catheter and the cutting toolpositioned at a treatment site in a blood vessel.

FIG. 75 illustrates an example in which the catheter and the cuttingtool are advanced separately in a blood vessel.

FIG. 76 illustrates an example of the catheter and the cutting tooldisposed on another catheter in a blood vessel.

FIG. 77 illustrates an example of the stent deployed in a stenoticregion of the blood vessel.

FIG. 78 illustrates an example of a balloon positioned within thedeployed stent.

FIG. 79 illustrates an example of a balloon inflated within the deployedstent to treat the stenotic region.

FIG. 80 is a cutaway view of a balloon disposed on a guidewire assemblyaccording to embodiments disclosed herein.

FIG. 81 illustrates an example of the stent deployed in a stenoticregion of the blood vessel with the balloon on the guidewire assemblypositioned within the deployed stent.

FIG. 82 illustrates an example of the balloon on the guidewire assemblyinflated within the deployed stent to treat the stenotic region.

FIGS. 83A-84E schematically illustrate various views of the devicedeployed at the aneurysm and stagnation of blood flow within theaneurysm.

FIGS. 85A-85D illustrate fluoroscopic images of various views of thedevice deployed at the aneurysm and stagnation of blood flow within theaneurysm.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. It willbe apparent, however, to one ordinarily skilled in the art that thesubject technology may be practiced without some of these specificdetails. In other instances, well-known structures and techniques havenot been shown in detail so as not to obscure the subject technology.

Occluding Device

FIG. 1 illustrates a typical cerebral aneurysm 10. A neck 11 of theaneurysm 10 can typically define an opening of between about 2 to 25 mm,though other sizes and ranges are also possible. As is understood, theneck 11 connects the vessel 13 to the lumen 12 of the aneurysm 10. Ascan be seen in FIG. 1, the blood flow 3 within the vessel 13 ischanneled through the lumen 12 and into the aneurysm. In response to theconstant blood flow into the aneurysm, the wall 14 of lumen 12 continuesto distend and presents a significant risk of rupturing. When the bloodwithin the aneurysm 10 causes pressure against the wall 14 that exceedsthe wall strength, the aneurysm ruptures. An aspect of the subjecttechnology may prevent or reduce likelihood of such ruptures. Also shownin FIG. 1 are a bifurcation 15 and side branches 16.

FIG. 2 illustrates one embodiment of a vascular device 200 in accordancewith an aspect of the disclosure. In the illustrated embodiment, theoccluding device 200 has a substantially tubular structure 22 defined byan outer surface 21, an inner surface 24 and a thin wall that extendsbetween the surfaces 21, 24. A plurality of openings 23 extend betweenthe surfaces 21, 24 and allow for fluid flow from the interior of thevascular device 200 to the wall of the vessel. Vascular device 200 isradially compressible and longitudinally adjustable.

In some embodiments, the vascular device is referred interchangeablywith vascular occluding device and occluding device. These terms arebroad terms and are intended to have their ordinary meaning and areintended to include, unless expressly otherwise stated or incompatiblewith the description of, each of the stents and other vascular devicesdescribed by this specification or descriptions of stents or othervascular devices that are incorporated by reference herein.

FIG. 3 shows a catheter 25 and the occluding device 200 inside thecatheter 25 in a compressed state prior to being released within thevasculature of the patient.

FIG. 4 illustrates another embodiment of the occluding device 30 havingtwo or more strands of material(s) 31, 32 wound in a helical fashion.The braiding of such material in this fashion results in a latticestructure 33. As can be understood, the dimension of the lattice 33 andthe formed interstices 34 is determined, at least in part, by thethickness of the strand materials, the number of strands and the numberof helices per unit length of the occluding device 30. For example, theinterstices 34 and/or the dimension of the lattice 33 may be determinedby the number of strands of material(s) 31, 32 wound in helical fashion.In some embodiments, any number of braiding ribbons up to 16 braidingribbons may be used (e.g., 5, 8, 10, 13, 15 or 16 braiding ribbons). Insome embodiments, 16-32 braiding ribbons may be used (e.g., 20, 23, 25,27, 30, or 32 braiding ribbons). In some embodiments greater than 32braiding ribbons may be used such as, for example, 35, 40, 48, 50, 55,60, 80, 100, or greater braiding ribbons. In some embodiments, 48braiding ribbons are used.

Hence, strands of material, such as ribbons, may intersect to form abraid pattern. The intersection of the strand material may be formed ineither a radial or axial direction on a surface of a forming device suchas a braiding mandrel. When the intersection of the strand material isalong an axial path, for example, the intersecting material may be at afixed or variable frequency. As one example of strand materialintersecting at a fixed frequency, the intersecting strand material maybe along any 1.0 inch axial path on the surface of the forming device(e.g., a braiding mandrel) to indicate the pick count. When theintersection of the strand material is along a radial path orcircumferential path, the spacing of the strand material may beuniformly or variably distributed. In one example of the strand materialalong a radial or circumferential path in which the spacing is uniformlydistributed, the spacing along the radial direction may be determinedbased on Equation 1:(π)×(forming device diameter)/(# ribbons/2)  Eq. (1)

FIG. 18 illustrates an example of braiding elements or cells in theradial and PPI (picks per inch) directions. Any single element of thebraid (i.e., braid element) may be combined to form a mesh pattern asillustrated in FIG. 17 on a surface of a forming device (e.g., braidingmandrel). The braid is capable of impeding or disrupting the some typesof fluid flow (e.g., blood) in a lumen of a patient (e.g., bloodvessel). The braid or lattice pattern, density, shape, etc. when theoccluding device is deployed in the vessel, may at least partiallydetermine the flow within the vessel. Each of the parameters of thebraid or lattice may also be controlled by a user to control flow.

Parameters for determining the flow through an occluding devicecontaining a lattice pattern, density, shape, etc. include surfacecoverage of the occluding device and cell size of the braid or latticepattern. Each of these parameters may further characterize the geometryof the braid or lattice. Surface coverage may be determined as (surfacearea)/(total surface area), where the surface area is the surface areaof the frame or solid element and the total surface area is of theentire element (i.e., frame and opening).

Cell size may be determined as the greater length defining a cellopening. Braiding patterns that increase surface coverage whiledecreasing cell size may have an increased effect on disrupting orimpeding the flow through the braid or lattice. Each of the parametersof surface coverage and cell size may further be enhanced by varying thewidth of the strand material (e.g., the ribbons), increasing the numberof strands of strand material defining the braid, and/or increasing thePPI.

The braiding or lattice pattern as described may be further defined byvarious parameters including, for example, the number of strands (e.g.,ribbons), the width of each ribbon/strand, the braiding PPI, and/or thediameter of the forming device (e.g., mandrel diameter), to name a few.In some embodiments, the diameter of each strand is between about 0.001inches and 0.0014 inches. In some embodiments, the diameter of eachstrand is between about 0.0005 inches and 0.0020 inches. In someembodiments, the diameter of each strand is less than or equal to about0.0005 inches or greater than about 0.0020 inches.

Based on the lattice parameters, a leg length and a ribbon angle may bedetermined. The leg length may define the length of an aspect of thebraiding element. For example, if the braiding element is diamond shapedas illustrated in FIG. 17, the length of one side of the diamond shapedbraiding element is the “leg length.” A ribbon angle may define theangle created by two intersecting aspects of the braiding element. Inthe example illustrated in FIG. 17, the ribbon angle is the angle formedbetween two adjacent sides of the diamond shaped braiding element.Radial spacing of braid elements in a lattice pattern can define thewidth of a braiding element in radial direction. FIG. 18 illustrates anexample of a radial spacing, leg length and ribbon angle of a braidelement.

Radial spacing of the lattice may be determined as set forth in Equation2 as follows:Radial Spacing=(π)×(forming device diameter)/(# ribbons/2)  Eq. (2)

The braiding element may be fitted into a vessel based on the radialspacing or the diameter of the vessel. The radial spacing of the latticemay be adjusted based on the diameter of the vessel. For example, if thediameter of the vessel is small, the radial spacing may be adjusted to asmaller dimension while the leg length of the braid elements may bemaintained. Also in this example, the ribbon angle may also be adjustedto achieve the adjusted radial spacing. Adjusting the ribbon angle mayalso alter the spacing of the braid element in the PPI direction.

FIG. 19 illustrates an example of determining a radial spacing andribbon angle of a lattice structure in an occluding device. In thisexample, a lattice or braid contains sixteen interlacing ribbons, witheach ribbon being about 0.004 inches wide and braided on a formingdevice such as a mandrel with a diameter of about 4.25 mm and 65 PPI.Thus, in this example, the number of braiding elements is sixteen, theribbon width is about 0.004 inches, the spacing in the PPI direction isabout 1/65=0.01538 inches and the diameter of the forming device (e.g.,mandrel diameter) is about 4.25 mm. Hence, the radial spacing may becalculated as:

Radial  spacing = (π) × (forming  device  diameter)/(#  ribbons/2) = (3.14) × (0.425/2.54)/(16/2) = 0.0657  inches.FIG. 19 illustrates an example of a braiding element with a radialspacing of about 0.0657 inches. In addition, the leg length of theexample is about 0.0337 inches, the ribbon angle is about 153.65degrees, and the spacing of the braiding element in the PPI direction,based on the ribbon angle and leg length is about 0.0154 inches.

In some embodiments, the braiding pattern can include a “1 over 1 under1” pattern. In some embodiments, the braiding pattern can include a “1over 2 under 2” pattern. In some embodiments, the braiding pattern caninclude other variations of braids.

FIG. 20 illustrates the example of FIG. 19 after the braiding element isfitted into an appropriate vessel diameter. In this example, the radialspacing is adjusted to a smaller length to accommodate a smaller vesseldiameter. The leg length remains constant at about 0.0337 inches so theribbon angle changes based on changes in the radial spacing. In thisexample, the radial spacing is adjusted to about 0.06184 inches and theribbon angle is adjusted to about 132.79 degrees. Also, the spacing ofthe braid element in the PPI direction is also changed. In this example,the spacing of the braid element in the PPI direction increases fromabout 0.0154 inches to about 0.0270 inches.

Table 1 illustrates additional examples of lattice or braid patterns ofvarying PPI, ribbon width (RW), or number of ribbons. In addition, eachof the braid patterns in Table 1 may produce patterns with the samepercent coverage within a vessel.

TABLE 1 # ribbons 16 32 48 64 Braid diameter (mm) 4.25 4.25 4.25 4.25Braid diameter (in) 0.16732 0.16732 0.16732 0.16732 PPI 65.00 130.00275.00 260.00 RW (mils) 4.0000 2.0000 1.3000 1.0000 Node Spacing (ppi)0.01538 0.00769 0.00364 0.00385 Node Spacing (radial) 0.06571 0.032850.02190 0.01643 Ribbon Angle (ppi) 153.65 153.65 161.13000 153.62 LegLength (in) 0.03374 0.01687 0.0111 0.00844 Vessel diameter (mm) 4 4 4 4In-vessel device Node 0.06184 0.03092 0.02061 0.01546 spacing In-vesseldevice Ribbon 132.79 132.79 136.37 132.70 Angle (ppi) In-vessel device0.02702 0.01351 0.00825 0.00677 Node spacing (ppi) In-vessel device PPI37.01 74.04 121.21 147.72 In-vessel device braided 0.00024814 0.000062030.00002641 0.00001551 closed area (in²) In-vessel device Braided0.00058741 0.00014680 0.00005861 0.00003681 Open Area (in²) In-vesseldevice coverage 29.7% 29.7% 31.06% 29.64% In-vessel device total0.00083555 0.00020883 0.00008502 0.00005232 area (in²) In-vessel devicecell 1.317 0.658 0.430 0.329 size (mm)

The occluding device may be placed into a protective coil to enhanceplacement of the occluding device in a vessel. Also, the occludingdevice may be housed in a delivery device, such as a catheter, forplacement within a vessel. The occluding device may be created at a sizeor dimension based on the size of the protective coil, delivery device,or catheter housing the occluding device. For example, the number ofstrands or ribbons in the lattice structure of the occluding device thatfit into a corresponding protective coil, delivery device, or cathetermay be determined such that the occluding device is effectively storedor housed prior to deployment in a vessel. In one example, the strandsof the occluding device may overlap in a 2-layer structure including aninner layer and an outer layer, the outer layer contacting theprotective coil.

In some embodiments, the braiding diameter is 0.25 mm larger than therecommended vessel size. In some embodiments, the percent coverage bythe stent of the vessel wall is about ⅓, or 33% of the total surfacearea when the stent is placed within the vessel. In some embodiments,the braiding PPI (picks per inch, or the number of wire crossings perinch) is 275 PPI. In some embodiments, the braid is manufactured over ametal core or mandrel, and the braiding is not too dense to hinderremoval of the braiding from the metal core or mandrel. In someembodiments, the PPI of the stent, when implanted within the vessel, isabout 100 PPI. In some embodiments, the diameter of the strands of thestent ranges from about 0.001 inch to about 0.0014 inch. In someembodiments, the number of strands selected for a stent is based on thedesired diameter of the stent. For example, in some embodiments, 48strands are used for a stent diameter ranging from about 2.75 mm toabout 4.25 mm, 64 strands are used for a stent diameter ranging fromabout 4.5 mm to about 6.0 mm, 72 strands are used for a stent diameterranging from 6.0 mm and greater, and 32 strands are used for a stentdiameter ranging from 2.5 mm and smaller. In some embodiments, thenumber of strands is selected based on a diameter of the deliverycatheter.

In one example, a housing such as a protective coil, delivery device orcatheter that houses the occluding device may have a constant size ordiameter and the characteristics of the occluding device may bedetermined to fit the housing. For example, a ribbon size or width maybe determined based on the desired size of the housing. In this way, thesize (or diameter) of the housing (e.g., protective coil, deliverydevice or catheter) may be constant for a variety of occluding devicesthat may vary in size or number of ribbons.

FIG. 21 illustrates an example of a cross sectional view of a protectivecoil. In this example, a number of strands or ribbons in a latticestructure of an occluding device is determined for a protective coil.The protective coil illustrated in FIG. 21 has a circular crosssectional area with a diameter. A strand or ribbon of a predeterminedthickness or size is placed within the protective coil such that theouter surface of the strand/ribbon contact the inner surface of theprotective coil. The inner surface of the strand/ribbon creates aconcave surface within the protective coil. A second strand/ribbon isplaced within the protective coil such that the outer surface of thesecond strand/ribbon contacts an inner circumference in contact with theconcave surface of the strand/ribbon previously placed in the protectivecoil. The angle from a center point of the circular protective coil fromone edge of the second strand/ribbon to an opposite edge of the secondstrand/ribbon is determined (i.e., the “arc-angle”). Based on thesemeasurements, the number of strands or ribbons of the predetermined sizeor thickness may be determined using Equation 3a or 3b:(Arc−angle)×(# ribbons/2)≤360 degrees  Eq. (3a)# ribbons≤720 degrees/Arc−angle  Eq. (3b)

In the example illustrated in FIG. 21, an occluding device isconstructed using approximately a 0.001 inch by 0.004 inch ribbon. Thearc-angle of the ribbon element at the center of the protective coilbetween a first line drawn from the center point of the protective coilto one edge of an inner layer ribbon and a second line drawn from thecenter point of the protective coil to the opposite edge of the innerlayer ribbon is about 34.14 degrees. Thus, the calculated number ofribbons is less than or equal to about 720 degrees/34.14 degrees=20ribbons.

Table 2 illustrates additional examples of different designs for loadinga lattice structure of an occluding device in a protective coil.

TABLE 2 # ribbons 16 32 64 Protective Coil ID (in) 0.017 0.017 0.017Ribbon Width (in) 0.004 0.002 0.001 Ribbon Thickness (in) 0.001 0.0010.001 Inner Circle Angle 36.98 17.83 8.84 Max # Ribbons fitting in innercircle 9.73 20.19 40.72 # ribbons in inner circle 8 16 32

FIG. 22 illustrates another example of determining ribbon dimensions foran occluding device in a protective coil or a delivery device. In thisexample, an occluding device with a lattice or braid structure based ona thickness of a ribbon. As FIG. 22 illustrates, the diameter of theprotective coil or delivery device 2301 is about 0.0170 inches. A firstribbon 2302 is fitted within the outer surface of the protective coil ordelivery device 2301. A second ribbon 2303 is placed in contact with aninner circumference of the protective coil or delivery device 2301 wherethe inner circumference is a circumference that is tangential to theinner surface of the first ribbon 2302. The second ribbon 2303 is placedwithin the inner circumference such that lateral ends of the secondribbon 2303 are in contact with the inner circumference of theprotective coil or delivery device 2301. The arc-angle between a firstline extending from the center point of the protective coil or deliverydevice 2301 to one lateral end of the second ribbon 2303 and a secondline extending from the center point of the protective coil or deliverydevice 2301 to the other lateral end of the second ribbon 2303 iscalculated as illustrated in FIG. 22.

In this example, the maximum dimensions of the first and second ribbons2302, 2303 are determined based on the calculated arc-angle formed. Forexample, to allow eight ribbons in the inner circumference of theprotective coil or delivery device 2301, the arc-angle may be calculatedas (360 degrees)/8=45 degrees as FIG. 22 illustrates. Based on a 45degree angle, the maximum ribbon width may be determined as about0.00476 inches to allow eight ribbons of a thickness of about 0.001inches to fit within the inner circumference of the protective coil ordelivery device 2301. As used herein, the term “maximum” is a broadterm, and is intended to mean, without limitation, a desired upper rangeof a particular parameter, and the term “minimum” is a broad term, andis intended to mean, without limitation, a desired lower range of aparticular parameter. In some embodiments, the parameters explainedherein, described as maximum, can extend greater than or beyond themaximum range, and parameters explained herein, described as minimum,can extend less than or beyond the minimum range.

In another example, a narrower ribbon width is used to compensate formaterial tolerance variations and curvature. Based on extensive researchand experimentation by the applicants, it was discovered that atolerance range applied to the ribbon widths of about 20% can compensatefor such material tolerance variations. FIG. 23 illustrates an exampleof a 20% tolerance range or cushion applied to ribbon widths of anoccluding device.

In this example, 20% additional ribbons are desired in the occludingdevice (i.e., 1.20×8=9.6 ribbons). The maximum width of the ribbons maybe determined based on the desired number of 9.6 ribbons by calculatingthe angle as described above. Specifically, the arc-angle may becalculated as (360 degrees)/9.6=37.7 degrees. Based on this calculation,the maximum width of the ribbons may be determined as about 0.00405inches as illustrated in FIG. 23. Thus, in this example, a 20% cushionis applied to permit about 9.6 ribbons in the protective coil ordelivery device at a maximum width of about 0.00405 inches.

Table 3 provides additional examples of ribbon widths for various ribbonthicknesses. In the examples provided in Table 3, the ribbon thicknessesrange from about 0.0007 inches to about 0.0015 inches.

TABLE 3 Ribbon Calculated max 20% cushion Thickness (in) width (in)width (in) 0.0005 0.00543 00.000463 0.0006 0.00530 0.00452 0.00070.00516 0.00440 0.0008 0.00503 0.00428 0.0009 0.00490 0.00417 0.00100.00476 0.00405 0.0011 0.00463 0.00393 0.0012 0.00450 0.00382 0.00130.00436 0.00370 0.0014 0.00422 0.00358 0.0015 0.00409 0.00346

In another example, an occluding device containing 32 ribbons isdescribed. FIG. 24 illustrates an example of determining the ribbonwidth of a 32-ribbon occluding device based on the number of ribbonsthat can fit in the protective coil or delivery device 2501. In thisexample, the protective coil or delivery device 2501 has a diameter ofabout 0.017 inches and the maximum ribbon width that can fit in theinner circumference of the protective coil or delivery device 2501provides an arc-angle of about (360 degrees)/(32/2)=22.5 degrees asillustrated in FIG. 24. Hence, to fit 16 ribbons along the innercircumference of the protective coil 2501, the width of the ribbons isdetermined to be about 0.00266 inches, with a thickness of about 0.00080inches as illustrated in FIG. 24. Similarly a 20% cushion may be appliedto the ribbon widths to provide for narrower ribbon widths to compensatefor material tolerance variations. In this example, the modified ribbonwidths may be determined based on the new arc-angle requirement of about(360 degrees)/19.2=18.75 degrees. Table 4 provides maximum ribbon widthsfor a 32-ribbon occluding device.

TABLE 4 Ribbon Calculated max 20% cushion Thickness (in) width (in)width (in) 0.0005 0.00288 0.00242 0.0006 0.00281 0.00235 0.0007 0.002730.00229 0.0008 0.00266 0.00223 0.009 0.00258 0.00216 0.0010 0.002510.00210

Alternatively, a larger number of ribbons may be included in theoccluding device. For example, the strands or ribbons may be increasedto greater than 32, such as 40, 44, 48, 50, 56, 60, 64, 70, 76, 80, 90,100, or more. For any desired number of ribbons, a ribbon width may bedetermined based on a calculated angle or a ribbon thickness asdescribed. In addition, a cushion may be applied to the ribbon width asdescribed.

In another example, oversized occluding devices may be used relative tothe vessel. For example, a larger occluding device relative to the sizeof the vessel lumen may result in enhanced anchoring of the occludingdevice within the lumen of the vessel. FIG. 25 illustrates arelationship between the PPI of the occluding device in place in thevessel (“in-vessel PPI”) versus the PPI of the occluding device in thefree-standing state (“braided PPI”). The graph in FIG. 25 demonstratesthat for each design, the PPI of the occluding device in place in thevessel approaches a maximum value as the pick count of the occludingdevice in the free-standing state increases. For example, for the 4 mmvessel design, as the PPI of the free-standing occluding device isincreased, the PPI of the occluding device in the vessel increases untilthe in-vessel PPI reaches about 45. When the in-vessel PPI reaches about45, further increases in the braided PPI result in only minimal furtherincreases in the in-vessel PPI. Also illustrated in FIG. 25, differentvessel designs (e.g., 3 mm vessel design or 5 mm vessel design) resultin a similar behavior in which the in-vessel PPI approaches a maximumvalue for high braided pick counts.

Similarly, FIG. 28 illustrates the in-vessel PPI as a function of thebraided PPI of a 32 ribbon occluding device. In the examples illustratedin FIG. 28, the PPI of the occluding device in a vessel (“in-vesselPPI”) approaches a higher value as the PPI of the occluding device in afree-standing state (“braided PPI”). FIG. 28 also illustrates alternatevessel designs. As can be seen in the examples of vessel designs of FIG.28, for each of the vessel designs, the in-vessel PPI approaches ahigher value asymptotically as the braided PPI increases.

Similarly, the coverage of the occluding device may be based on ribbonwidth or braided PPI. FIG. 26 illustrates an example in which the ribbonis about 0.00467 inches wide and 0.001 inches and is the greater ribbonsize that fits in the protective coil. As FIG. 26 illustrates, thecoverage approaches a greater value of approximately 65-100 PPI range.In this example, the percentage of coverage asymptotically approachesapproximately 40% for a 0.001″×0.00467″ ribbon and 34% for a0.001″×0.004″ ribbon.

FIG. 29 illustrates the percent coverage as a function of the braidedPPI for a 32 ribbon occluding device. As FIG. 29 demonstrates, the %coverage approaches a greater value as the braided PPI in increases. Forexample, for an occluding device containing about 0.0008×0.00266 inchribbons, the percent coverage approaches a greater value of about 43% asthe braided PPI increases above about 150. Also, for an occluding devicecontaining about 0.0008×0.0020 inch ribbons, the percent coverageapproaches a greater value of about 35% as the braided PPI increasesabove about 150.

FIG. 27 is a graph showing the opening sizes of braiding elements in theoccluding device as a function of the PPI of the lattice structure. Asthe PPI increases, the opening sizes or spaces through which flow offluid (e.g., blood) decreases. As the PPI of the lattice structurereaches about 100, the opening sizes of the braiding elements when inplace in a vessel asymptotically approaches a minimum value. In theexamples illustrated in FIG. 27, for a ribbon size of about 0.001×0.004inches, the opening sizes of the braiding elements in the latticestructure of an occluding device in a vessel approaches about 1280microns or less. Similarly, for a ribbon size of about 0.001×0.00467inches, the opening sizes of the braiding elements in the latticestructure of an occluding device in a vessel approaches about 1220.

FIG. 30 illustrates the opening sizes of braiding elements in theoccluding device as a function of the braided PPI of the latticestructure for a 32 ribbon occluding device. As FIG. 30 demonstrates, theopening size of braiding elements approaches a lower value as thebraided PPI in increases. For example, for an occluding devicecontaining about 0.0008×0.00266 inch ribbons, the opening sizeapproaches a lower value of about less than 600 microns as the braidedPPI increases above about 150. Also, for an occluding device containingabout 0.0008×0.0020 inch ribbons, the opening sizes approaches a lowervalue of about 640 as the braided PPI increases above about 150.

The occluding device 30 is radially compressible and radially expandablewithout the need for supplemental radially expanding force, such as aninflatable balloon. The occluding device 30 is constructed by windingthe two strands (31, 32) in opposite directions. Alternatively, greaterthan 2 strands may be wound in various directions. For example, 8, 10,12, 14, 22, 28, 30, 32, 36, 40, 44, 48, 52, 58, 64, 70, 86, 90, 110,116, 120, 128, 136, 150, or greater strands may be wound in variousdirections. In an embodiment, the strands 31, 32 are in the shape ofrectangular ribbon (See FIG. 4C). The ribbons can be formed of knownflexible materials including shape memory materials, such as Nitinol,platinum and stainless steel. In some embodiments, the occluding device30 is fabricated from platinum/8% tungsten and 35NLT (cobalt nickelalloy, which is a low titanium version of MP35N alloy) alloy wires.

The ribbon used as the braiding material for the strands 31, 32 caninclude a rectangular cross section 35 (FIG. 4C). As shown in FIGS. 4Cand 7, the surface 36 that engages an inner surface of the vessel has alonger dimension (width) when compared to the wall 38 that extendsbetween the surfaces 36, 37 (thickness). A ribbon with rectangular crosssection has a higher recovery (expansive) force for the same wallthickness when compared to a wire with a circular (round) cross section.Additionally, a flat ribbon allows for more compact compression of theoccluding device 200 and causes less trauma to the vascular wall whendeployed because it distributes the radial expansion forces over agreater surface area. Similarly, flat ribbons form a more flexibledevice for a given lattice density because their surface area (width) isgreater for a given thickness in comparison to round wire devices.

While the illustrated embodiment discloses a ribbon having a rectangularcross section in which the length is greater than its thickness, theribbon for an alternative embodiment of the disclosed occluding devicesmay include a square cross section. In another alternative embodiment, afirst portion of the ribbon may include a first form of rectangularcross section and a second portion 39 of the ribbon (FIG. 4B) mayinclude a round, elliptical, oval or alternative form of rectangularcross section. For example, end sections of the ribbons may havesubstantially circular or oval cross section and the middle section ofthe ribbons could have a rectangular cross section.

In an alternative embodiment as described above, the occluding device 30can be formed by winding more than two strands of ribbon. In anembodiment, the occluding device 30 could include as many as sixteenstrands of ribbon. In another embodiment, the occluding device 30 caninclude as many as 32 strands of ribbon, as many as 48 strands ofribbon, as many as 60 strands of ribbon, as many as 80 strands ofribbon, as many as 100 strands of ribbon, as many as 150 strands ofribbon or greater than 150 strands of ribbon, for example. By usingstandard techniques employed in making radially expanding stents, onecan create an occluding device 30 with interstices 34 that are largerthan the thickness of the ribbon or diameter of the wire. The ribbonscan have different widths. In such an embodiment, the differentribbon(s) can have different width(s) to provide structure support tothe occluding device 30 and the vessel wall. The ribbons according tothe disclosed embodiments can also be formed of different materials. Forexample, one or more of the ribbons can be formed of a biocompatiblemetal material, such as those disclosed herein, and one or more of theribbons can be formed of a biocompatible polymer.

FIG. 5 shows the intravascular occluding device 30 in a radiallycompressed state located inside the catheter 25. In one embodiment, theoccluding device 30 could be physically attached to the catheter tip.This could be accomplished by constraining the occluding device 30 inthe distal segment of the catheter. The catheter 25 is slowly advancedover a guidewire (not shown) by a plunger 50 and when the tip of thecatheter 25 reaches the aneurysm, the occluding device is released fromthe tip. The occluding device 30 expands to the size of the vessel andthe surface of the occluding device 30 is now apposed to the vessel wall15 as shown in FIG. 6.

With reference to FIG. 7, the occluding device 30 is deployed inside thelumen of a cerebral vessel 13 with an aneurysm 10. During itsdeployment, the proximal end 43 of the occluding device 30 is securelypositioned against the lumen wall of the vessel 13 before thebifurcation 15 and the distal end 45 of the occluding device 30 issecurely positioned against the lumen wall of the vessel 13 beyond theneck 11 of aneurysm 10. After the occluding device 30 is properlypositioned at the desired location within the vessel 13 (for example,see FIG. 7), flow inside the lumen of aneurysm 10 is significantlyminimized while the axial flow within the vessel 13 is not significantlycompromised, in part due to the minimal thickness of the walls 38.

The flow into the aneurysm 10 will be controlled by the lattice densityof the ribbons and the resulting surface coverage. Areas having greaterlattice densities will have reduced radial (lateral) flow. Conversely,areas of lesser lattice densities will allow greater radial flow throughthe occluding device 30. As discussed below, the occluding device 30 canhave longitudinally extending (lateral) areas of different densities. Ineach of these areas, their circumferential densities can be constant orvary. This provides different levels of flow through adjacent lateralareas. The location within a vessel of the areas with greater densitiescan be identified radiographically so that the relative position of theoccluding device 30 to the aneurysm 10 and any vascular branches 15, 16can be determined. The occluding device 30 can also include radiopaquemarkers.

The reduction of blood flow to or within the aneurysm 10 results in areduction in force against the wall 14 and a corresponding reduction inthe risk of vascular rupturing. When the force and volume of bloodentering the aneurysm 10 is reduced by the occluding device, the laminarflow into the aneurysm 10 is stopped and the blood within the aneurysmbegins to stagnate. Stagnation of blood, as opposed to continuous flowthrough the lumen 12 of the aneurysm 10, results in thrombosis in theaneurysm 10. This also helps protect the aneurysm from rupturing.Additionally, due to the density of the portion of the occluding device30 at the bifurcation 15, the openings (interstices) 34 in the occludingdevice 30 allow blood flow to continue to the bifurcation 15 and theside branches 16 of the vessel. If the bifurcation 15 is downstream ofthe aneurysm, as shown in FIG. 8, the presence of the occluding device30 still channels the blood away from the aneurysm 10 and into thebifurcation 15.

In some embodiments, the lattice density of the occluding device 30 maybe adjusted so as to result in a delayed occlusion. For example, thelattice density of the occluding device 30 may be configured togradually reduce the flow of blood into the aneurysm 10 to result insubstantial thrombosis in the aneurysm 10 within a time frame afterdeploying the occluding device 30 to treat the aneurysm. In someembodiments, substantial thrombosis refers to between about 90% andabout 95% of the blood within the aneurysm 10 clotting. In someembodiments, substantial thrombosis refers to between about 50% and 99%of the blood within the aneurysm 10 clotting. In some embodiments,substantial thrombosis refers to between about 80% and 95% of the bloodwithin the aneurysm 10 clotting. In some embodiments, substantialthrombosis refers to between about 70% and 98% of the blood within theaneurysm 10 clotting. In some embodiments, substantial thrombosis refersto between about 60% and 99% of the blood within the aneurysm 10clotting. In some embodiments, substantial thrombosis refers to lessthan or equal to about 50% of the blood within aneurysm 10 clotting. Insome embodiments, substantial thrombosis refers to sufficient clottingof the blood within the aneurysm 10 such that the threat of rupture ofthe aneurysm 10—for example from the blood flow 3—is reduced oreliminated.

In some embodiments, the time frame associated with the delayedocclusion is about 3 months after deploying the occluding device 30 totreat the aneurysm. In some embodiments, the time frame is between about2 months and about 4 months. In some embodiments, the time frame isbetween about 1 month and about 5 months. In some embodiments the timeframe is less than or equal to about 1 month or greater than about 5months. In some embodiments, the time frame is between about 2 weeks andabout 4 weeks. In some embodiments, the time frame is between about 3weeks and about 6 weeks.

The lattice density of the occluding device 30 may be appropriatelyadjusted to achieve an optimum time frame for delayed occlusion. In someembodiments, the lattice density to achieve an optimum time frame fordelayed occlusion is between about 60% and about 95%. In someembodiments, the lattice density to achieve an optimum time frame fordelayed occlusion is between about 30% and about 60%. In someembodiments, the lattice density to achieve an optimum time frame fordelayed occlusion is less than or equal to about 30% or greater thanabout 95%. In some embodiments, the lattice density can be combined withother features of the stent to achieve delayed occlusion. For example,the lattice density may be combined with specific features of theindividual strands (e.g., cross-section, diameter, perimeter) or thebraiding patterns.

In some embodiments, the time associated with sufficient occlusion isabout 3 hours after deploying the occluding device 30 to treat theaneurysm. In some embodiments, the time is between about 2 hours andabout 4 hours. In some embodiments, the time frame is between about 1hour and about 5 hours. In some embodiments the time frame is less thanor equal to about 1 hour or greater than about 5 hours. In someembodiments, the time frame is between about 2 hours and about 4 hours.In some embodiments, the time frame is between about 3 hours and about 6hours.

At least some of the embodiments of the occluding devices describedherein have flexibility to conform to the curvature of the vasculature.This is in contrast to coronary stents that cause the vasculature toconform essentially to their shape. The ability to conform to the shapeof the vasculature (e.g., in radial compression, bending along an axisof the stent or vasculature, etc.) can be more significant for someneurovascular occluding devices than for some coronary stents, as thevasculature in the brain tends to be smaller and more tortuous.

Tables 5 and 6 demonstrate characteristics of a neurovascular occludingdevice. To demonstrate that the disclosed occluding devices exhibit verydesirable bending characteristics, the following experiment wasperformed. An occluding device made by the inventors was set on asupport surface 90 as shown in FIG. 9. About 0.5 inches of the occludingdevice 30 was left unsupported. Then, a measured amount of force wasapplied to the unsupported tip until the occluding device was deflectedby about 90 degrees from the starting point.

A similar length of a coronary stent was subjected to the same bendingmoment. The results are shown in Table 5. Similar to the reducedcompressive force, the occluding device of the present disclosure mayrequire an order of magnitude lower bending moment (0.005 lb-in comparedto 0.05 lb-in for a coronary stent). In some embodiments, the braidingpattern, stent diameter, number of ribbons, and other parameters can beadjusted to such that the bending force ranges from about 0.0005 lb-into about 0.05 lb-in. In some embodiments, the bending force can rangefrom about 0.00025 lb-in to about 0.03 lb-in, from about 0.003 lb-in toabout 0.05 lb-in, from about 0.005 lb-in to about 0.01 lb-in, from about0.01 lb-in to about 0.05 lb-in, from about 0.0025 lb-in to about 0.01lb-in. In some embodiments, the bending force can range less than about0.005 lb-in or greater than about 0.05 lb-in.

TABLE 5 Bending Force Required to Bend a 0.5″ Cantilever Made by theOcclusion Device Coronary stent  0.05 lb-in Neurovascular OccludingDevice (30) 0.005 lb-in

The occluding devices according to the present disclosure also providesenhanced compressibility (i.e., for a given force how much compressioncould be achieved or to achieve a desired compression how much forceshould be exerted) compared to coronary stents. An intravascular devicethat is not highly compressible is going to exert more force on thevessel wall compared to a highly compressible device. This is ofsignificant clinical impact in the cerebral vasculature as it isdetrimental to have an intravascular device that has lowcompressibility.

In some embodiments, the braiding pattern, stent diameter, number ofribbons, and other parameters can be adjusted such that the compressiveforce required to compress the stent 50% of the original diameter rangesfrom about 0.01 lb to about 0.5 lb. In some embodiments, the compressiveforce can range from about 0.05 lb to about 0.15 lb, from about 0.07 lbto about 0.1 lb, from about 0.03 lb to about 0.18 lb, from about 0.08 lbto about 0.19 lb, and from about 0.04 lb to about 0.3 lb. In someembodiments, the bending force can range less than about 0.01 lb orgreater than about 0.5 lb.

TABLE 6 Compressive Force Required to Compress the Occluding device to50% of the Original Diameter (See FIG. 10) Coronary stent  0.2 lbNeurovascular Occluding device (30) 0.02 lb

FIGS. 33-36 illustrate additional and/or other embodiments of theoccluding device 3000. The occluding device 3000 may be expanded orcompressed. For example, the entire occluding device 3000, or portionsof the occluding device 3000, may be compressed or expanded in an axialdirection, radial direction, or both. The occluding device 3000 may bein various configurations or states depending on whether the occludingdevice 3000 is expanded or compressed.

In some embodiments, when the occluding device 3000 is in a certainstate, the occluding device 3000 may remain in the same state withoutany external forces acting on the occluding device 3000. For example,when the device is in an expanded state, when external forces areremoved from the device, such that no external forces are acting on thedevice, the device will remain in the expanded state. In someembodiments, when the occluding device 3000 is in a certain state, theoccluding device 3000 may change to a different state without anyexternal forces acting on the occluding device 3000. For example, whenthe device is in a compressed state, when external forces are removedfrom the device, such that no external forces are acting on the device,the device will change to the expanded state.

In some instances, the occluding device 3000 comprises walls 3014 thatmay change automatically from a compressed configuration (e.g., in arestrained state) to an expanded configuration (e.g., in an unrestrainedstated), or vice versa. The walls 3014 may also change from an expandedconfiguration to a hyperexpanded configuration (e.g., another restrainedstate), and vice versa. The walls 3014 may exert an expanding force inany direction and/or a compressive force in any direction to allow theoccluding device 3000 to change from any one state to another state.

In some embodiments, the walls 3014 may have a spring constant k thatcauses the stent to require a force to change from an expanded,unrestrained state to a compressed state. In some embodiments, thespring constant is of the stent and/or filaments is configured such thatthe force is between 0.2 lb and about 0.02 lb. For example, the force tochange the stent can be between 0.02 lb and 0.1 lb in some embodiments,0.1 lb and 0.15 lb in some embodiments, and 0.15 lb and 0.2 lb in someembodiments. In some embodiments, the spring constant is such that theforce is less than or equal to about 0.02 lb or greater than or equal toabout 0.2 lb.

The walls 3014 may also have a wall thickness that varies depending onthe configuration of the occluding device 3000. In some embodiments, thewall thickness is between about 2 strands and about 4 strands thick whenthe occluding device 3000 is in the compressed configuration. In someembodiments, the wall thickness is between about 4 strands and about 6strands thick when the occluding device 3000 is in the compressedconfiguration. In some embodiments, the occluding device 3000 is lessthan or equal to about 2 strands or greater than about 6 strands thickwhen the occluding device 3000 is in the compressed configuration. Insome embodiments, the wall thickness is between about 2 strands andabout 4 strands thick when the occluding device 3000 is in the expandedconfiguration. In some embodiments, the wall thickness is less than orequal to about 2 strands or greater than about 4 strands thick when theoccluding device 3000 is in the expanded configuration. In someembodiments, the wall thickness is between about 2 strands and about 5strands thick when the occluding device 3000 is in the hyperexpandedconfiguration (a configuration beyond the unrestrained, expandedconfiguration). In some embodiments, the wall thickness is less than orequal to about 2 strands or greater than about 5 strands thick when theoccluding device 3000 is in the hyperexpanded configuration.

In another example, FIG. 33 shows the occluding device 3000 in acompressed configuration. The occluding device 3000 may be in acompressed configuration, for example, when it is stored in the catheter25 shown in FIG. 5. The walls 3014 of the occluding device 3000, in acompressed configuration, may exert a radially expansive force and alongitudinally compressive force to change from the compressedconfiguration to an expanded configuration. FIG. 34 illustrates theoccluding device 3000 in an expanded configuration. Thus, afterdeploying the occluding device 3000 from a catheter into a vessel, theoccluding device may change from a compressed configuration, asillustrated in FIG. 33, to an expanded configuration, as illustrated inFIG. 34.

The occluding device 3000 may further be changed from the expandedconfiguration into a hyperexpanded configuration, as illustrated in FIG.35. The walls 3014 of the occluding device 3000, in a hyperexpandedconfiguration, may exert a longitudinally expansive force to change theoccluding device 3000 from the hyperexpanded configuration back to theexpanded configuration. In some embodiments, the lattice density of theoccluding device 3000 is increased when the occluding device 3000changes from the expanded configuration to the hyperexpandedconfiguration. In some embodiments, the lattice density of the occludingdevice 3000 in the expanded configuration is between about 25% and about35%. In some embodiments, the lattice density of the occluding device3000 in the expanded configuration is between about 35% and about 50%.In some embodiments, the lattice density of the occluding device 3000 inthe expanded configuration is less than or equal to about 25% or greaterthan about 50%. Correspondingly, the lattice density of the occludingdevice 3000 in the hyperexpanded configuration, in some embodiments, isbetween about 50% and about 70%. In some embodiments, the latticedensity of the occluding device 3000 in the hyperexpanded configurationis between about 70% and about 95%. In some embodiments, the latticedensity of the occluding device 3000 in the hyperexpanded configurationis less than or equal to about 50% or greater than about 95%.

Furthermore, the entire occluding device 3000 or portions of theoccluding device 3000 may expand or compress. Correspondingly, thelattice density of the entire occluding device 3000 or the latticedensity of portions of the occluding device 3000 may decrease orincrease depending on whether an expansive or compressive force,respectively, is applied to the occluding device 3000.

Additionally, the length of the occluding device 3000 may changedepending on whether the occluding device 3000 is expanded or compressedin the axial direction. The length of the occluding device 3000 maydecrease when the occluding device 3000 is compressed in the axialdirection. Alternatively, the length of the occluding device 3000 mayincrease when the occluding device 3000 is expanded in the axialdirection. For example, the length 3008 of the occluding device 3000 inthe expanded configuration (FIG. 34) may be less than or about equal tothe length 3004 of the occluding device 3000 in the compressedconfiguration (FIG. 33). This may occur because the walls 3014 of theoccluding device 3000 in a compressed configuration are exerting alongitudinally compressive force to change into the expandedconfiguration. Similarly, the length 3008 of the occluding device 3000in the expanded configuration (FIG. 34) may be greater than or aboutequal to the length 3012 of the occluding device 3000 in thehyperexpanded configuration (FIG. 35). This may occur because the walls3014 of the occluding device 3000 in the hyperexpanded configuration areexerting a longitudinally expansive force to change into the expandedconfiguration.

The diameter of the occluding device 3000 may also change depending onwhether the occluding device 3000 is expanded or compressed in theradial direction. The diameter indicates the cross-sectional open areaof the occluding device 3000. Correspondingly, the cross-sectional openarea of the occluding device 3000 changes depending on whether theoccluding device 3000 is expanded or compressed in the radial direction.The diameter of the occluding device 3000 may decrease when theoccluding device 3000 is compressed in the radial direction.Alternatively, the diameter of the occluding device 3000 may increasewhen the occluding device 3000 is expanded in the radial direction. Forexample, the diameter 3006 of the occluding device 3000 in the expandedconfiguration (FIG. 34) may be greater than or about equal to thediameter 3002 of the occluding device 3000 in the compressedconfiguration (FIG. 33). This may occur because the walls 3014 of theoccluding device 3000 in the compressed configuration are exerting aradially expansive force to change into the expanded configuration.Similarly, the diameter 3006 of the occluding device 3000 in theexpanded configuration (FIG. 34) may be less than or about equal to thediameter 3010 of the occluding device 3000 in the hyperexpandedconfiguration (FIG. 35). This may occur because the walls 3014 of theoccluding device 3000 in the hyperexpanded configuration are exerting aradially compressive force to change into the expanded configuration.

In some embodiments, the diameter of the occluding device 3000 does notincrease when changing from the expanded configuration into thehyperexpanded configuration. For example, applying a longitudinallycompressive force to the occluding device 3000 in the expandedconfiguration (thus, decreasing the length 3008) to change into thehyperexpanded configuration does not cause the diameter of the occludingdevice 3000 to increase. In some embodiments, changing the length of theoccluding device 3000, such as by applying a longitudinally compressiveor expansive force, does not change the diameter of the occluding device3000. In some embodiments, changing the diameter of the occluding device3000, such as by applying a radially compressive or expansive force,does not change the length of the occluding device 3000. FIGS. 36A, 36Band 36C illustrate various examples of relationships between the lengthand the diameter of the occluding device 3000. As shown in FIG. 36A,point 3602 represents the greater length and the lesser diameter of theoccluding device 3000. Point 3602 represents the greater length 3612 andthe lesser diameter 3614 that the occluding device 3000 can be“stretched” to. That is, by applying a longitudinally expansive forceand/or a radially compressive force on the occluding device 3000,occluding device 3000 may reach this point 3602.

The greater length 3612 or the lesser diameter 3614 of the occludingdevice 3000 may vary depending on the treatment that the occludingdevice 3000 is used for, the materials used in making occluding device3000, the size of any storage or deployment devices utilizing theoccluding device 3000, or other factors. In some embodiments, thegreater length 3612 of the occluding device 3000 is between about 2times and about 5 times the unrestrained length 3616. In someembodiments, the greater length 3612 is between about 5 times and about10 times the unrestrained length 3616. In some embodiments, the greaterlength 3612 is less than or equal to about 2 times or greater than about10 times the unrestrained length 3616. In some embodiments, the greaterlength 3612 may be when the occluding device 3000 is placed within acatheter. The greater length 3612 may be longer or shorter than thecatheter. In some embodiments, the greater length 3612 when theoccluding device 3000 is placed within a catheter is between about 40 mmand about 60 mm. In some embodiments, the greater length 3612 when theoccluding device 3000 is placed within a catheter, the greater length3612 is between about 25 mm and about 75 mm. In some embodiments, thegreater length 3612 when the occluding device 3000 is placed within acatheter, the greater length 3612 is less than or equal to about 25 mmor greater than about 75 mm.

In some embodiments, the lesser diameter 3614 of the occluding device3000 is between about 1% and about 5% of the unrestrained diameter 3618.In some embodiments, the lesser diameter 3614 is between about 0.5% andabout 10% of the unrestrained diameter 3618. In some embodiments, thelesser diameter 3614 is between about 2% and about 15% of theunrestrained diameter 3618. In some embodiments, the lesser diameter3614 is between about 3% and about 20% of the unrestrained diameter3618. In some embodiments, the lesser diameter 3614 is less than orequal to about 0.5% or greater than about 20% of the unrestraineddiameter 3618. In some embodiments, the lesser diameter 3614 may be whenthe occluding device 3000 is placed within a catheter. In someembodiments, the lesser diameter 3614 when the occluding device 3000 isplaced within a catheter is between about 0.026 inches and about 0.027inches. In some embodiments, the lesser diameter 3614 when the occludingdevice 3000 is placed within a catheter is between about 0.020 inchesand about 0.03 inches. In some embodiments, the lesser diameter 3614when the occluding device 3000 is placed within a catheter is less thanor equal to about 0.020 inches or greater than about 0.03 inches.

Intervals 3608 (as represented by intervals 3608 a, 3608 b, 3608 c, 3608d, 3608 e through 3608 n in FIG. 36A) represent any of the states of theoccluding device 3000 when the occluding device 3000 is in a compressedconfiguration and/or changing from a compressed configuration into anexpanded configuration or vice versa. In some embodiments, the length ofthe occluding device 3000 does not vary with the diameter of theoccluding device 3000. In some embodiments, the length of the occludingdevice 3000 varies with the diameter of the occluding device 3000 in anymanner, such as linearly, inversely, exponentially, or logarithmically.

Point 3604 represents the unrestrained length 3616 and the unrestraineddiameter 3618 of the occluding device 3000 when the occluding device3000 is in the expanded configuration. The unrestrained length 3616 orthe unrestrained diameter 3618 of the occluding device 3000 may alsovary depending on the treatment that the occluding device 3000 is usedfor, the materials used in making occluding device 3000, the size of anystorage or deployment devices utilizing the occluding device 3000, orother factors. For example, the unrestrained length 3616 may beappropriately long enough for the treatment of aneurysms, such as beingat least being longer than the neck of an aneurysm. In some embodiments,the unrestrained length 3616 is between about 8 mm and about 10.5 mm. Insome embodiments, the unrestrained length 3616 is between about 5 mm andabout 15 mm. In some embodiments, the unrestrained length 3616 is lessthan or equal to about 5 mm or greater than about 15 mm.

The unrestrained diameter 3618 of the occluding device 3000 may at leastbe approximately greater than the diameter of the blood vessel in whichthe occluding device 3000 is deployed in. That is, the unrestraineddiameter 3618 may be greater than the diameter of the vessel such that africtional force created between the contact of the occluding device3000 and the walls of the vessel is great enough to prevent or reducethe likelihood the occluding device 3000 from migrating through thevessel. In some embodiments, the unrestrained diameter 3618 is betweenabout 2.25 mm and about 5.25 mm. In some embodiments, the unrestraineddiameter 3618 is between about 1.75 mm and about 6.5 mm. In someembodiments, the unrestrained diameter 3618 is less than or equal toabout 1.75 mm or greater than about 6.5 mm.

In some embodiments, the number of strands that may be used foroccluding device 3000 depends on the unrestrained diameter 3618. In someembodiments, about 48 strands may be used for occluding device 3000 foran unrestrained diameter 3618 between about 2.75 mm and about 4.25 mm.In some embodiments, about 64 strands may be used for occluding device3000 for an unrestrained diameter 3618 between about 4.5 mm and about6.0 mm. In some embodiments, about 72 strands may be used for occludingdevice 3000 for an unrestrained diameter 3618 greater than or equal toabout 6.0 mm. In some embodiments, about 32 strands may be used foroccluding device 3000 for an unrestrained diameter 3618 less than orequal to about 2.5 mm. These ranges and values can vary depending ondesired properties, such as diameters and porosity.

Interval 3610 represents any of the states of the occluding device 3000when the occluding device 3000 is in a hyperexpanded configurationand/or changing from an expanded configuration into a hyperexpandedconfiguration or vice versa. In some embodiments, decreasing the lengthof the occluding device 3000, for example by applying a longitudinallycompressive force, does not cause the diameter of the occluding device3000 to increase. Rather, the diameter may remain substantially the sameas illustrated by interval 3610.

Point 3606 represents the lesser length 3620 and a greater diameter 3618of the occluding device 3000. The lesser length 3620 and the greaterdiameter 3618 of the occluding device 3000 may also vary depending onthe treatment that the occluding device 3000 is used for, the materialsused in making occluding device 3000, or other factors. For example, thelesser length 3620 may be small enough to allow for the greater latticedensity needed to treat an aneurysm or other diseases. In someembodiments, the lesser length 3620 is between about 30% and about 50%of the unrestrained length 3616. In some embodiments, the lesser length3620 is between about 50% and about 75% of the unrestrained length 3616.In some embodiments, the lesser length 3620 is less than or equal toabout 30% or greater than about 75% of the unrestrained length 3616. Insome embodiments, the greater diameter 3618 is the same as theunrestrained diameter 3618. In some embodiments, the greater diameter3618 is 110% of the unrestrained diameter 3618. In some embodiments, thegreater diameter 3618 is between about 101% and about 115% of theunrestrained diameter 3618. In some embodiments, the greater diameter3618 is less than or equal to about 101% or greater than about 115% ofthe unrestrained diameter 3618.

FIG. 36B illustrates an example of a relationship between the length3624 (as shown by lengths 3624 a and 3624 b) and the diameter 3626 ofthe occluding device 3000 (as shown by occluding devices 3000 a and 3000b). The occluding device 3000 a may be in a first configuration, andcomprises a first length 3624 a, a diameter 3626, and a first latticedensity 3622 a. A longitudinally expansive force may be applied to theoccluding device 3000 a. In some embodiments, applying a longitudinallyexpansive force decreases the lattice density and increases the length.For example, by applying a longitudinally expansive force to theoccluding device 3000 a in the first configuration, the occluding device3000 a may expand into a second configuration of the occluding device3000 b. Thus, the second lattice density 3622 b may be lower than thefirst lattice density 3622 a, and the second length 3624 b may begreater than the first length 3624 a.

Similarly, in some embodiments, applying a longitudinally compressiveforce increases the lattice density and decreases the length. Forexample, by applying a longitudinally compressive force to the occludingdevice 3000 b in the second configuration, the occluding device 3000 bmay compress into the first configuration of the occluding device 3000a. Thus, the first lattice density 3622 a may be greater than the secondlattice density 3622 b, and the first length 3624 a may be lower thanthe second length 3624 b. In some embodiments, applying a longitudinallycompressive or expansive force does not change the diameter 3626 of theoccluding device 3000. For example, the diameter 3626 remainssubstantially the same between the occluding device 3000 a in the firstconfiguration and the occluding device 3000 b in the secondconfiguration.

FIG. 36C illustrates an example of a relationship between the length3630 and the diameter 3632 (as shown by diameters 3632 a and 3632 b) ofthe occluding device 3000 (as shown by occluding devices 3000 a and 3000b). The occluding device 3000 a may be in a first configuration, andcomprises a length 3630, a first diameter 3632 a, and a first latticedensity 3628 a. A radially expansive force may be applied to theoccluding device 3000 a. In some embodiments, applying a radiallyexpansive force decreases the lattice density and increases thediameter. For example, by applying a radially expansive force to theoccluding device 3000 a in the first configuration, the occluding device3000 a may expand into a second configuration of the occluding device30006. Thus, the second lattice density 3628 b may be lower than thefirst lattice density 3628 a, and the second diameter 3632 b may begreater than the first diameter 3632 a.

Similarly, in some embodiments, applying a radially compressive forceincreases the lattice density and decreases the diameter. For example,by applying a radially compressive force to the occluding device 3000 bin the second configuration, the occluding device 3000 b may compressinto the first configuration of the occluding device 3000 a. Thus, thefirst lattice density 3628 a may be greater than the second latticedensity 3628 b, and the first diameter 3632 a may be lower than thesecond diameter 3632 b. In some embodiments, applying a radiallycompressive or expansive force does not change the length 3630 of theoccluding device 3000. For example, the length 3630 remainssubstantially the same between the occluding device 3000 a in the firstconfiguration and the occluding device 3000 b in the secondconfiguration.

FIGS. 11-13 show an embodiment of the occluding device 60 in which thelattice structure 63 of the occluding device 60 is non-uniform acrossthe length of the occluding device 60. In the mid-section 65 of theoccluding device 60, which is the section likely to be deployed at theneck of the aneurysm, the lattice density 63 a is intentionallyincreased to a value significantly higher than the lattice densityelsewhere in the occluding device 60. For example, as seen in FIG. 11A,lattice density 63 a is significantly higher than the lattice density 63in adjacent section 64. FIGS. 11B-11G illustrates other examples inwhich the lattice density varies across the length of the occludingdevice 60. In some examples, the sections of the occluding device 60with higher lattice densities 63 a may be at the end, the middle, orother locations of the occluding device 60. The occluding device 60 mayalso have different lattice densities across the length of the occludingdevice 60. For example, as shown in FIGS. 11F and 11G, the occludingdevice 60 may have a section with a lattice density 63 b which is higherthan lattice density 63 and lower than lattice density 63 a. At oneextreme, the lattice density could be 100%, i.e., the occluding device60 is completely impermeable. In another embodiment, the lattice density63A in mid-section 65 could be about 50%, while the lattice density inthe other sections 64 of the occluding device is about 25%. FIG. 12shows such an occluding device 60 in a curved configuration and FIG. 13shows this occluding device 60 deployed in the lumen of a vessel. FIG.13 also illustrates the part of the occluding device 60 with increasedlattice density 63A positioned along the neck of aneurysm 10. As withany of the disclosed occluding devices, the lattice density of at leastone portion of occluding device 60 can be between about 20% and about30%. In some embodiments, the lattice density of at least one portion ofoccluding device 60 can be between about 30% and 65%. In someembodiments, the lattice density of at least one portion of occludingdevice 60 can be between about 65% and 95%. In some embodiments, thelattice density of at least one portion of occluding device 60 can beless than or equal to about 20% or greater than about 95%.

In some embodiments, increasing the lattice density of a portion of thestent decreases a porosity of stent portion. Conversely, decreasing thelattice density of a stent portion increases the porosity of the stentportion. In some embodiments, the changing of the lattice density, orporosity, is called packing or dynamic packing.

The occluding device 60 may also be described in terms of porosity.According to one embodiment, the porosity of occluding device 60 may beequal to a ratio of an open surface area of the occluding device 60 to atotal surface area of the occluding device 60. Occluding device 60 maycomprise a plurality of braided strands, which forms pores in open areasbetween the strands.

In some embodiments, the pores have an average pore length. The averagepore length may be any pore length suitable for aneurysm treatment orother types of treatments. In some embodiments, the average pore lengthis about 0.43 mm. In some embodiments, the average pore length isbetween about 0.15 mm and about 0.40 mm. In some embodiments, theaverage pore length is between about 0.4 mm and about 0.65 mm. In someembodiments, the average pore length is less than or equal to about 0.15mm or greater than about 0.65 mm.

The pores may either increase or decrease in size depending on thestructure of the occluding device 60. For example, the porosity of aportion of the occluding device 60 can be reduced by longitudinallycompressing the portion of the occluding device 60. By longitudinallycompressing the portion of the occluding device 60, the open surfacearea decreases as the braided strands are compressed closer together,resulting in a reduced porosity.

When the longitudinally compressed portion of the occluding device 60 isunrestrained, the occluding device 60 may expand, resulting in anincreased porosity. In some embodiments, the porosity of occludingdevice 60 can be between about 70% and about 80%. In some embodiments,the porosity of occluding device 60 can be between about 35% and 70%. Insome embodiments, the porosity of occluding device 60 can be betweenabout 5% and 35%. In some embodiments, the porosity of occluding device60 can be less than or equal to about 5% or greater than about 80%.

In some embodiments, the porosity is related to the pore length. Forexample, in some embodiments, the porosity multiplied by the averagepore length is about 0.3 mm. In some embodiments, the porositymultiplied by the average pore length is between about 0.15 mm and about0.3 mm. In some embodiments, the porosity multiplied by the average porelength is between about 0.3 mm and about 0.45 mm. In some embodiments,the porosity multiplied by the average pore length is less than or equalto about 0.15 mm or greater than about 0.45 mm. In one example, theporosity at 70% multiplied by the average pore length at 0.43 mm gives0.3 mm.

In some embodiments, the porosity is related to the thickness of thebraided strands. The braided strands may have an average strandthickness. In some embodiments, the average strand thickness is about0.003 inches. In some embodiments, the average strand thickness isbetween about 0.001 inches and about 0.003 inches. In some embodiments,the average strand thickness is between about 0.003 inches and about0.005 inches. In some embodiments, the average strand thickness is lessthan or equal to about 0.001 inches or greater than about 0.005 inches.The braided strands may comprise a ribbon having a width greater thanits thickness. In other examples, the ribbon may have a width less thanor equal to its thickness. In some embodiments, the porosity multipliedby the average strand thickness is about 0.002 inches. In someembodiments, the porosity multiplied by the average strand thickness isbetween about 0.001 inches and about 0.002 inches. In some embodiments,the porosity multiplied by the average strand thickness is between about0.002 inches and about 0.004 inches. In some embodiments, the porositymultiplied by the average strand thickness is less than or equal toabout 0.001 inches or greater than about 0.004 inches. For example, theporosity at 70% multiplied by the average strand thickness at 0.003inches gives 0.002 inches.

In some embodiments, the pore size is related to the thickness of thebraided strands. In some embodiments, the average pore length multipliedby the average strand thickness is about 9.4×10⁻⁵ in². In someembodiments, the average pore length multiplied by the average strandthickness is between about 4×10−5 in² and about 14×10⁻⁵ in². In someembodiments, the average pore length multiplied by the average strandthickness is less than or equal to about 4×10⁻⁵ in² or greater thanabout 14×10⁻⁵ in². For example, the average pore length at 0.6 mmmultiplied by the average strand thickness at 0.004 inches results in avalue of 9.4×10⁻⁵ in².

In some embodiments, the porosity of occluding device 60 is related tothe volume of the pore and is configured to facilitate endotheliazationof the stented vessel. In such embodiments, that pore area can bemultiplied by the average or actual stent thickness to determine thevolume of space defined by each stent pore. By selecting a desired stentpore volume, endotheliazation of the stented vessel can be enhanced. Insome embodiments, other parameters may be used to optimize or enhancefunctions of the stent, such as the average pore length, the averagestrand thickness, the average pore size, or other dimensions.

Another embodiment of the occluding device 300 is shown in FIGS. 14 and15. In this embodiment, the occluding device 300 is deployed in lumen ofa vessel with an aneurysm. The occluding device 300 includes a surface310 that faces the lumen of the aneurysm. This surface 310 has asignificantly higher lattice density (smaller and/or fewer interstices)compared to the diametrically opposite surface 320. Due to the higherlattice density of surface 310, less blood flows into the lumen of theaneurysm. However, there is no negative impact on the blood flow to theside branches as the lattice density of the surface 320 facing the sidebranches is not reduced.

As set forth in the examples above, different portions of the occludingdevice may have different lattice densities such that flow of fluids orblood may be controlled based on the location within the occludingdevice. The lattice densities may further be controlled by an inputreceived at the occluding device. The input for controlling the latticedensities of different portions of the occluding device may include, forexample, a pressure or motion force applied to a portion of theoccluding device. The occluding device in this example may includehelically-wound material such as strands or ribbons in a latticestructure as described herein. The strands that are helically wound maybe movable relative to each other. For example, a first strand and asecond strand may be helically wound to form a lattice structure thatincludes crossing strands (the first strand and the second strand maycross over each other) interspersed with openings between the strands.

In another example, the lattice structure formed by crossing strands ofthe occluding device may be adjustable based on the input as described(e.g., motion, pressure or force input). When the input is received atthe occluding device, the strands may move relative to each other. Forexample, a portion of the first strand may move closer to acorresponding portion of the second strand and a second portion of thefirst strand may also move farther from a corresponding first portion ofthe second strand. Hence, in this example, the spacing between the firstand second strands of helically wound material forming the latticestructure of the occluding device may vary to create different latticedensities. Different portions of an occluding device may have differentlattice densities when strands in one portion of the occluding devicemove closer to each other while strands in another portion of theoccluding device move farther away from each other.

Also, the relative movement of the strands may be controlled based on aninput received at the occluding device. As set forth above, the inputmay include any type of input for moving or adjusting the occludingdevice including, for example, pressure, force, motion, rotation, orother similar input.

The occluding device be placed into a blood vessel and a certain portionof the occluding device may contain a high lattice density whileretaining a lower lattice density in a different portion of theoccluding device. The received input may control the placement and/orlattice density of the occluding device to achieve a desired latticedensity at a selected portion of the occluding device. Thus, the inputreceived at the occluding device may cause a first portion of theoccluding device to have a first lattice density and a second portion ofthe occluding device to have a second lattice density in which the firstlattice density and the second lattice density are different.

In one example, a user may insert the occluding device into the bloodvessel and may apply pressure on the occluding device to cause anadjustment of the lattice density of the occluding device. In anotherexample, a motion force may be applied to the occluding device such thatthe strands of the occluding device forming the lattice structure maymove relative to one another in at least one portion of the occludingdevice. The strands may also be rearranged differently at differentportions of the occluding device such that the lattice density may varyfrom one portion of the occluding device to another portion of theoccluding device.

For example, the occluding device may include a lattice densityadjusting implement such that pressure exerted by the lattice densityadjusting implement on a portion of the occluding device may cause thelattice density of the portion of the occluding device acted upon by thelattice density adjusting implement to obtain a desired lattice density.FIG. 31 illustrates an example of an occluding device 3101 containing alattice density adjusting implement 3102 for adjusting the latticedensity at any desired portion of the occluding device 3101. The usermay exert a force on a proximal end of the lattice density adjustingimplement 3102 which may cause a distal end of the lattice densityadjusting implement to adjust the lattice material for altering thelattice density. In addition, movement of the lattice density adjustingimplement 3102 may enable a user to adjust the lattice density of anydesired portion of the occluding device. In some embodiments, thelattice density adjusting implement 3102 is not required to adjust thelattice density.

The occluding device may further be administered and positioned into avessel via a delivery device. For example, a delivery device may includea tubular structure such as a catheter through which the occludingdevice may be placed into a vessel. The delivery device may furtherinclude the lattice density adjusting implement 3102 that may be used toadjust the lattice density of the occluding device. The lattice densityadjusting implement 3102 may further adjust the lattice density only atone portion of the occluding device while not affecting other portionsof the occluding device, if desired. Alternatively, the lattice densityadjusting implement 3102 may be used to increase the lattice density atone portion of the occluding device while decreasing the lattice densityat another portion of the occluding device. The lattice densityadjusting implement 3102 may be controlled by pressure or motion forcesapplied via the delivery device.

In one example, the lattice density adjusting implement 3102 may beconnected to a wire to a proximal end of the delivery device. The usermay apply a force to the proximal end of the wire at the proximal end ofthe delivery device. The force applied which may be a pressure or motionforce, for example, may cause corresponding movement of the latticedensity adjusting implement 3102. The movement of the lattice densityadjusting implement 3102 may further contact strands of the occludingdevice to move the strands. The movement of the strands of the occludingdevice may cause a change in the lattice density in at least one portionof the occluding device. Hence, user input may control a lattice densityadjusting implement 3102 to cause varying lattice densities in selectedportions of the occluding device.

In another example, the lattice density of the occluding device may beadjusted based on movement of the occluding device, or part of thedevice, in a blood vessel. For example, the occluding device may beplaced and moved within a blood vessel. As the occluding device is movedin the blood vessel, the lattice density in selected portions of theoccluding device may be adjusted accordingly. The lattice density in oneportion of the occluding device may increase while the lattice densityin another portion of the occluding device may increase, decrease orstay the same. In one example, the occluding device contacts a wall ofthe blood vessel and a force is applied to a proximal end of theoccluding device. For example a user may apply a force to a proximal endof the occluding device. This force, which may be a pressure or motionforce, for example, may be applied at a proximal end of a deliverydevice through which the occluding device may be positioned in a vesseland may be adjusted in the vessel. The applied force causes the strandsor ribbons of the occluding device to adjust such that the latticedensity in the occluding device varies based on the portion of theoccluding device.

As one example, the occluding device contains intertwining ribbonsforming a lattice structure with a lattice density. The occluding deviceis introduced to a site in a blood vessel of an aneurysm. The occludingdevice is further applied to the portion of the blood vessel at andaround the aneurysm as illustrated in FIG. 7. The outer sides of theoccluding device may be in contact with at least a portion of the bloodvessel in areas surrounding the aneurysm, however, the outer side of theoccluding device at the site of the aneurysm does not contact a wall ofthe blood vessel. This may be because the aneurysm is situated such thatthe wall of the aneurysm protrudes outward from the wall of the surroundblood vessel such that the outer sides or surface of the occludingdevice does not directly contact the inner surface of the wall of theaneurysm.

Pressure may be applied to, for example, a proximal end of the occludingdevice. In this example, the lattice structure of the occluding deviceis freely adjustable such that the pressure may cause movement of thelattice structure of the occluding device in a distal direction.Frictional forces acting on the occluding device from the inner surfaceof the walls of the blood vessel in contact with the outer sides orsurfaces of the occluding device may impede movement of the latticestructure in areas of the occluding device in contact with the wall ofthe blood vessel. However, gradual movement of the occluding device inthe blood vessel can be accomplished by application of pressure or forceat the proximal end of the occluding device.

In some embodiments, a portion of the occluding device overlying theneck of the aneurysm does not contact the walls of the blood vessel.Because this portion of the occluding device subject to less frictionalforces as compared to the portion of the occluding device in directcontact with the inner wall of the blood vessel, the lattice structureof the occluding device overlying the aneurysm may change as the appliedforce causes the portion of the occluding device proximal to theaneurysm to move distally to cause an increase in force applied to theportion of the occluding device overlying the aneurysm. Also, thesection of the occluding device overlying the blood vessel wall distalto the aneurysm may be subject to higher frictional forces than thatapplied to the portion of the occluding device overlying the aneurysm.As a result, in some embodiments, the lattice density of the occludingdevice overlying the aneurysm is increased. In some embodiments, thelattice density of the occluding device either does not increase orincreases to a lesser degree than the portion of the occluding deviceoverlying the aneurysm.

In another example, an aneurysm may be located at a branching of a bloodvessel as illustrated in FIG. 32. The occluding device is placed suchthat a first portion 3201 of the occluding device may be locatedproximal to a blood vessel branch and aneurysms. A second portion 3202of the occluding device may be located overlying the blood vessel branch3208, a third portion of the occluding device may be located overlying aportion of the blood vessel distal to the blood vessel branch 3208 andproximal to a first aneurysm 3209, a fourth portion of the occludingdevice may be located overlying the first aneurysm 3209, a fifth portionof the occluding device may overlie the portion of the blood vesseldistal to the first aneurysm 3209 and proximal to a second aneurysm3210. A sixth portion of the occluding device may overlie the secondaneurysm 3210. Blockage of blood flow to the aneurysms may be desired,however, blockage of blood flow to the branched blood vessel may not bedesired.

In this example, a user may apply a pressure or force to a proximal endof an occluding device to cause a portion of the occluding device toadvance in the blood vessel in a distal direction. The first portion3201 of the occluding device (proximal to the blood vessel branch 3208and the aneurysms 3209 and 3210) may transmit the force to more distalportions of the occluding device, including the second portion 3202 ofthe occluding device located over the blood vessel branch 3208. Thefrictional force impeding advancement of the occluding device in thesecond portion 3202 of the occluding device is low because the secondportion 3202 of the occluding device does not contact the wall (orcontacts it less than the first portion) of the blood vessel directly.Rather, the second portion 3202 of the occluding device overlies a bloodvessel branch 3208 as illustrated in FIG. 32. Hence, the lattice densityin the second portion 3202 of the occluding device increases as thefirst portion 3201 of the occluding device transfers the force to thesecond portion 3202 of the occluding device. Also a negative forceapplied to the occluding device may cause the lattice density in thesecond portion 3202 of the occluding device to decrease, thus permittingflow of blood into the blood vessel branch 3208.

The second portion 3202 of the occluding device also transfers the forceto the third portion 3203 of the occluding device overlying the portionof blood vessel distal to the blood vessel branch 3208. However, thefrictional forces acting on the third portion 3203 of the occludingdevice is higher than those frictional forces acting on the secondportion 3202 because the third portion 3203 of the occluding device isin contact with the wall of the blood vessel. Hence, the lattice densityof the occluding device in the third portion 3203 is initially lowerthan the lattice density of the occluding device in the second portion3202.

The force applied to the third portion 3203 of the occluding device(overlying and in contact with the portion of the blood vessel distal tothe blood vessel branch 3208 and first aneurysm 3209) is transferred tothe fourth portion 3204 of the occluding device, which is the portion ofthe occluding device overlying the first aneurysm 3209. The frictionalforces acting on the fourth portion 3204 of the occluding device islower than the frictional forces acting on the third portion 3203 of theoccluding device because the fourth portion 3204 of the occluding deviceis not in direct contact with the inner wall of the blood vessel. Hence,the pressure applied to the fourth portion 3204 of the occluding devicecauses the lattice density in the fourth portion 3204 of the occludingdevice to increase.

Also, the force applied to the fourth portion 3204 of the occludingdevice may be transferred to the fifth portion 3205 of the occludingdevice, which is in contact with the portion of the blood vessel betweenthe first aneurysm 3209 and the second aneurysm 3210. The frictionalforce acting on the fifth portion 3205 of the occluding device isgreater than the frictional force acting on the fourth portion 3204 ofthe occluding device because at least a portion of the fifth portion3205 of the occluding device is in contact with the inner wall of theblood vessel. However, the fourth portion 3204 of the occluding deviceoverlies the second aneurysm 3209 and is not in contact with the wall ofthe blood vessel. Hence, the difference in the frictional forces appliedto the portions of the occluding device results in controlled changes inthe lattice density of different portions of the occluding device inthis example.

Also illustrated in FIG. 32 is the sixth portion 3206 of the occludingdevice that overlies the second aneurysm 3210. The frictional forcesacting upon the sixth portion 3206 of the occluding device is less thanthe frictional force acting on the fifth portion of the occluding device3205 because the sixth portion 3206 of the occluding device does notcontact a wall of the blood vessel directly. Therefore, the forcetransferred from the fifth portion 3205 of the occluding device to thesixth portion 3206 of the occluding device may cause the lattice densityof the sixth portion 3206 to increase. Hence, the lattice density of thefourth portion and the sixth portion of the occluding device may beincreased by application of a pressure or motion force at the occludingdevice. Also, retraction of the occluding device such as by pulling aproximal end of the occluding device proximally may cause the latticedensity of the second portion of the occluding device to decrease. Thismay cause increased flow of blood and/or fluids into the blood vesselbranch 3208 while impeding flow of blood and/or fluids into the first orsecond aneurysms (3209, 3210).

FIG. 37 illustrates another embodiment of the occluding device 3700. Theoccluding device 3700 may be utilized to treat various forms ofaneurysms. For example, the occluding device 3700 may be used to treatan aneurysm 3702 (as shown by aneurysm portions 3702 a, 3702 b and 3702c), which is a fusiform aneurysm. The occluding device 3700 may bedeployed such that a distal portion 3710 of the occluding device 3700arrives at a target site to treat the aneurysm 3702. The occludingdevice 3700 may be deployed using any number of methods. For example, acatheter can store the occluding device 3700 in a compressedconfiguration and advance occluding device 3700 to the target site, uponwhich the distal portion 3710 of the occluding device 3700 is deployed.As the occluding device 3700 is deployed from the catheter, theoccluding device 3700 may expand into the expanded configuration. At thedistal portion 3710, the occluding device 3700 makes contact with thevessel wall distal to the aneurysm 3702. The catheter may further beretracted to deploy the rest of the occluding device 3700, for example,allowing a middle portion 3714 (as shown by 3714 a and 3714 b) and aproximal portion 3712 (as shown by 3712 a and 3712 b) to expand. Themiddle portion 3714, because of a greater diameter of the occludingdevice 3700 may not expand all the way to make contact with the aneurysmwalls 3716. The proximal portion 3712 of the occluding device 3700 maymake contact with the vessel walls proximal to the aneurysm 3702 afterexpanding from the compressed configuration into the expandedconfiguration.

The porosity of middle portion 3714 may be adjusted to reduce the bloodflow 3704 into the aneurysm 3702. For example, the porosity of themiddle portion 3714 can be reduced by applying a longitudinallycompressive force to the proximal portion 3712 of the occluding device3700 towards the direction of the distal portion 3710. Thelongitudinally compressive force may be greater than the frictionalforce caused by the contact between the proximal portion 3712 and thevessel walls. The longitudinally compressive force may continue to beapplied until the porosity of the middle portion 3714 has been reducedappropriately to treat the aneurysm 3702. The porosity of the middleportion 3714 may be adjusted by applying either a longitudinallycompressive force to the proximal portion 3712 or an axially expansiveforce to the proximal portion 3712 (e.g., by pulling proximal portion3712 against the direction of the blood flow 3704). A similar techniquemay be applied to the distal portion 3710 as well.

The porosity of middle portion 3714 b, specifically, may be adjusted sothat it is higher than the porosity of the middle portion 3714 a inorder to allow sufficient blood flow 3706 into branch vessel 3708 whileat the same time reducing blood flow to the aneurysm portion 3702 a.This can be achieved by applying a lower longitudinally compressiveforce to the proximal portion 3712 b relative to the proximal portion3712 a. Alternatively, the porosity of the middle portion 3714 b can beadjusted alone by applying either a longitudinally compressive force tothe proximal portion 3712 b or a longitudinally expansive force to theproximal portion 3712 b. For example, if the porosity of middle portion3714 b is too low to allow blood flow 3706 into branch vessel 3708, alongitudinally expansive force may be applied to proximal portion 3712 b(e.g., pulling on proximal portion 3712 b). This may result in themiddle portion 3714 b expanding to increase the porosity of the middleportion 3714 b, allowing more blood to flow into branch vessel 3708.Furthermore, the porosity of middle portion 3714 b may be adjusted byusing an adjusting implement (such as adjusting implement 3102 of FIG.31), as described above.

The porosity of the middle portion 3714 b may be adjusted such thatsubstantial thrombosis may occur within aneurysm 3702 while at the sametime allowing blood flow 3706 into branch vessel 3708. In someembodiments, the porosity of the middle portion 3714 b may be adjustedsuch that endotheliazation may occur outlining the blood flow 3706through the aneurysm 3702. For example, the porosity of the middleportion 3714 b may be adjusted such that substantial thrombosis mayoccur within aneurysm 3702, particularly within aneurysm portions 3702a, 3702 b and 3702 c, while at the same time allowing an endothelium3718 to develop around the aneurysm portions 3702 b and 3702 c,outlining the blood flow 3706. In some embodiments, the porosity of themiddle portion 3714 b to achieve this endotheliazation effect is betweenabout 5% and 35%. In some embodiments, the porosity of the middleportion 3714 b to achieve this endotheliazation effect is between about35% and about 70%. In some embodiments, the porosity of the middleportion 3714 b to achieve this endotheliazation effect is between about70% and 80%. In some embodiments, the porosity of the middle portion3714 b to achieve this endotheliazation effect is less than or equal toabout 5% or greater than about 80%.

This endotheliazation effect may be achieved depending on the foregoingfactors or other factors. For example, in some embodiments, applying adelayed occlusion as described above may result in such anendotheliazation effect. In some embodiments, the wall thickness ofmiddle portion 3714 b as described above may result in such anendotheliazation effect. In some embodiments, the pore size of the poresof middle portion 3714 b as described above may result in such anendotheliazation effect. In some embodiments, the width of the strandsor the thickness of the strands of middle portion 3714 b as describedabove may result in such an endotheliazation effect. In someembodiments, the shape of the strand as described above may result insuch an endotheliazation effect. In some embodiments, theendotheliazation effect may be achieved based on any of the foregoingfactors alone or in combination with any of the other factors.

Any of the occluding devices disclosed herein can be used with a secondoccluding device to create a bifurcated occluding device 400 as shown inFIG. 16. This device could be created in vivo. In forming the occludingdevice 400, a portion of a first occluding device 410 having a lowdensity can be combined with a portion of a second occluding device 410that also has a low density. The occluding devices 410, 420 can be anyof those discussed herein. After these portions of the two occludingdevices 410, 420 are combined in an interwoven fashion to form aninterwoven region 425, the remaining portions 414, 424 can branch off indifferent directions, thereby extending along two branches of thebifurcation. Areas outside of the interwoven region 425 can have greaterlattice density for treating an aneurysm or lesser lattice density forallowing flow to branches 15, 16 of the vessel.

Additional and/or other embodiments of the occluding device areillustrated in FIGS. 38-42. Multiple occluding devices may be utilizedwherein at least a portion of each of the occluding devices overlap witheach other. For example, FIG. 38 illustrates a first occluding device3800. A second occluding device 3900 may be deployed within the firstoccluding device 3800. In some embodiments, the first occluding device3800 and the second occluding device 3900 may be identical occludingdevices. Thus, the porosity of the first occluding device 3800 and thesecond occluding device 3900 may be the same when both devices areunrestrained. The overlapping portion 3850 of the first occluding device3800 and the second occluding device 3900 may provide a combinedporosity that is less than the porosity of the same portion of the firstoccluding device 3800 or the second occluding device 3900 alone. Thesecond occluding device 3800 may be deployed completely within the firstoccluding device 3900 or a portion of the occluding device 3800 may bedeployed within the first occluding device 3800, as shown in FIGS. 39and 41. Although two occluding devices are illustrated, more occludingdevices may be used in combination with each other to provide variouscombined porosities that may be substantially lower than the porosity anindividual occluding device may provide.

In some embodiments, the first occluding device 3800 may be deployedwithin a vessel 3806, as shown in FIG. 40 in a cross sectional view. Forexample, the first occluding device 3800 may be in a compressedconfiguration before deployment. Upon deploying the first occludingdevice 3800 within the vessel 3806, the first occluding device 3800expands into the expanded configuration with a first diameter 3804, thuscreating contact between the first occluding device 3800 and the wallsof the vessel 3806. The second occluding device 3900 may similarly bedeployed with at least a portion of the second occluding device 3900within the first occluding device 3800. For example, the secondoccluding device 3900 may be in a compressed configuration beforedeployment. Upon deploying the second occluding device 3900 within thefirst occluding device 3800 (which is already in the expandedconfiguration), the second occluding device 3900 expands into theexpanded configuration, thus creating contact between the secondoccluding device 3900 and either the inner wall 3802 of the firstoccluding device 3800, the walls of the vessel 3806, or both. Thisprocess may be repeated with more occluding devices to provide anappropriate combined porosity for aneurysm treatment or other types oftreatments.

Multiple occluding devices may be utilized to treat aneurysms asillustrated in FIG. 42. For example, the first occluding device 3800 maybe deployed to treat the aneurysm 4202 using similar techniques asdescribed above. The first occluding device 3800 comprises a distalportion 3810 and a proximal portion 3812, and extends such that theproximal portion 3812 is proximal to the aneurysm 4202 while the distalportion 3810 is distal to the aneurysm 4202. The second occluding device3900 may be deployed within the first occluding device 3800. The secondoccluding device 3900 comprises a distal portion 3910 and a proximalportion 3912. The second occluding device 3900 may be positioned suchthat the second occluding device 3900 is substantially adjacent to theaneurysm 4202. For example, the proximal portion 3912 of the secondoccluding device 3900 is positioned distal to the proximal portion 3812of the first occluding device 3800 and the distal portion 3910 of thesecond occluding device 3900 is positioned proximal to the distalportion 3810 of the first occluding device 3800.

The first occluding device 3800 and the second occluding device 3900 mayhave substantially the same porosity or different porosities whenunrestrained. The overlapping portion 3850 may result in a combinedporosity that is lower than the porosity of the first occluding device3800 or the porosity of the second occluding device 3900, resulting inreduced blood flow 4204 into aneurysm 4202. The combined porosity may beadjusted in various ways, for example by individually adjusting theporosity of the first occluding device 3800, the second occluding device3900, or by adding more occluding devices to decrease the combinedporosity. At one extreme, the combined porosity may be adjusted tosubstantially 0%, or any other porosity resulting in little to no bloodflow 4204 into aneurysm 4202, inducing substantial thrombosis within theaneurysm 4202 over time.

In one example, the porosity of the first occluding device 3800 may beadjusted before the second occluding device 3900 is deployed, usingsimilar techniques as described above. Subsequently, the porosity of thesecond occluding device 3900 may be adjusted upon deployment of thesecond occluding device 3900. For example, the distal portion 3910 ofthe second occluding device 3900 may be in a compressed configurationand advanced to an area proximal to the distal portion 3810 of the firstoccluding device 3800. The distal portion 3910 of the second occludingdevice 3900 may be allowed to expand to make contact with the firstoccluding device 3800. The rest of the second occluding device 3900 maybe deployed such that the porosity of the second occluding device 3900is decreased by allowing more portions of the second occluding device3900 to expand closer to the distal portion 3910 of the second occludingdevice 3900. Alternatively, the porosity of the second occluding device3900 can be increased by allowing more portions of the second occludingdevice 3900 to expand farther from the distal portion 3910 of the secondoccluding device 3900. Thus, the combined porosity may be adjusted byfirst adjusting the porosity of the first occluding device 3800 and thenadjusting the porosity of the second occluding device 3900 upondeployment.

In some embodiments, the combined porosity may be adjusted after boththe first occluding device 3800 and the second occluding device 3900have been deployed. For example, a longitudinally compressive force maybe applied to the proximal portion 3812 of the first occluding device3800 towards the direction of the distal portion 3810. The axiallycompressive force may be greater than the frictional force caused by thecontact between the proximal portion 3712 and the vessel walls. Thelongitudinally compressive force may continue to be applied until thecombined porosity of the overlapping portion 3850 has been reducedappropriately to treat the aneurysm 4202. In some embodiments, thesecond occluding device 3900 may expand and make contact with the firstoccluding device 3800 such that the longitudinally compressive forceapplied to the first occluding device 3800 is less than or equal to thefrictional force caused by the contact between the first occludingdevice 3800 and the second occluding device 3900. As a result, applyingthe longitudinally compressive force to the first occluding device 3800also causes the portion of the second occluding device 3900 in contactwith first occluding device 3800 to compress, resulting in a combinedreduced porosity. The combined porosity of the overlapping portion 3850may be adjusted by applying either a longitudinally compressive force tothe proximal portion 3812 or a longitudinally expansive force to theproximal portion 3812 (e.g., by pulling proximal portion 3812 againstthe direction of the blood flow 4204). A similar result can be achievedby applying the same technique to the proximal portion 3912 of thesecond occluding device 3900. Furthermore, similar techniques may alsobe applied to the distal portions 3810 and 3910 as well.

In some embodiments, the second occluding device 3900 may expand andmake contact with the first occluding device 3800 such that thelongitudinally compressive force applied to the first occluding device3800 is greater than the frictional force caused by the contact betweenthe first occluding device 3800 and the second occluding device 3900. Insuch a case, the porosity of the first occluding device 3800 or theporosity of the second occluding device 3900 may be adjusted independentof each other. For example, the porosity of any portion of the firstoccluding device 3800 may be adjusted applying either a longitudinallycompressive force to the proximal portion 3812 or a longitudinallyexpansive force to the proximal portion 3812. Similarly, the porosity ofany portion of the second occluding device 3900 may be adjusted byapplying either a longitudinally compressive force to the proximalportion 3912 or a longitudinally expansive force to the proximal portion3912. By individually adjusting the porosity of the first occludingdevice 3800 or the second occluding device 3900, the combined porosityof the overlapping portion 3850 may also be adjusted. Furthermore, theporosity of the overlapping portion 3850 may be adjusted by using anadjusting implement (such as adjusting implement 3102 of FIG. 31) andapplying a longitudinally compressive or expansive force to the portionsof the first occluding device 3800 or the second occluding device 3900.

The density of the lattice for each of the disclosed occluding devicescan be about 20% to about 80% of the surface area of its occludingdevice. In an embodiment, the lattice density can be about 20% to about50% of the surface area of its occluding device. In yet anotherembodiment, the lattice density can be about 20% to about 30% of thesurface area of its occluding device.

In another example, the lattice density of an occluding device may beadjusted or altered by user input such as a user input motion. The inputmotion may be in a longitudinal orientation. For example, an input forceor pressure may in a direction along a longitudinal axis of theoccluding device may be received at a portion of the occluding device.The portion of the occluding device may have a lattice density prior tothe application of the force, pressure or movement of the strands of theoccluding device in the portion of the occluding device receiving theinput force. The lattice density in the portion of the occluding devicemay change based on the received input. For example, the strands of theoccluding device may move in a longitudinal direction in the occludingdevice. Also, the longitudinal movement of strands of the occludingdevice may occur at a portion of the occluding device or may occur atthe entire occluding device. In the example of longitudinal movement ofstrands of the occluding device at a portion of the occluding device,the strands at the portion of the occluding device may move based on thereceived input such that the lattice density of the occluding device atthe portion of the occluding device receiving the input may increase.Alternatively, the lattice in a portion of the occluding device may alsodecrease in response to the input force, pressure or motion. Also, basedon the input force, pressure, or motion, the lattice density in a firstportion of the occluding device may increase while the lattice densityin a second portion of the occluding device may decrease or stay thesame. Hence, different portions of the occluding device may have adifferent movement based on an input received at the occluding devicesuch that one portion of the occluding device may have an increase ordecrease in lattice density while any other portion of the occludingdevice may have a decrease or increase in the lattice density.Alternatively, the lattice density in any of the portions of theoccluding device may stay the same.

A typical occluding device having sixteen strand braids with about 0.005inch wide ribbon, 30 picks per inch (PPI) (number of crosses/points ofcontact per inch), and about 0.09 inch outer diameter has approximately30% of lattice density (surface covered by the ribbon). In theembodiments disclosed herein, the ribbon can be about 0.001 inch thickwith a width of between about 0.002 inch to about 0.005 inch. In anembodiment, the ribbon has a thickness of about 0.004 inch. For a16-strands ribbon that is about 0.001 inch thick and about 0.004 inchwide, the coverage for 50 PPI, 40 PPI, and 30 PPI will have 40%, 32% and24% approximate surface coverage, respectively. For a 16-strands ribbonthat is about 0.001 inch thick and about 0.005 inch wide, the coveragefor 50 PPI, 40 PPI, and 30 PPI will be about 50%, 40% and 30%approximate surface coverage, respectively.

In choosing a size for the ribbon, one may consider whether, when theribbons are bundled up, they will slide through a delivery catheter. Forexample, sixteen strands of a 0.006 inch wide ribbon may not slidethrough a catheter having an internal diameter of about 0.027 inch orless as well as stents having a smaller contracted configuration.

While other strand geometry may be used, these other geometries, such asround, will limit the device due to their thickness dimension. Forexample, a round wire with about a 0.002 inch diameter may occupy up toabout 0.008 inch in cross sectional space within the vessel. This spacecan impact and disrupt the blood flow through the vessel. The flow inthe vessel can be disrupted with this change in diameter.

Occluding Device Assembly and Methods for Delivery

An occluding device delivery assembly having portions with small crosssection(s) and which is highly flexible is described herein. FIG. 43illustrates an introducer sheath 4 according to an aspect of thedisclosure that receives, contains and delivers an occluding device 100to a flexible catheter 1 for positioning within the vasculature of anindividual.

A distal end 7 of the introducer sheath 4 is sized and configured to bereceived within a hub 2 of the catheter 1, as shown in FIGS. 43 and 44.The hub 2 can be positioned at the proximal end of the catheter 1 or atanother location spaced along the length of the catheter 1. The catheter1 can be any known catheter that can be introduced and advanced throughthe vasculature of a patient. In an embodiment, the catheter has aninner diameter of about 0.047 inch or less. In another embodiment, thecatheter has an inner diameter of about 0.027 inch to about 0.021 inch.In an alternative embodiment, the catheter could have an inner diameterof about 0.025 inch. However, it is contemplated that the catheter 1 canhave an inner diameter that is greater than about 0.047 inch or lessthan about 0.021 inch. After the introducer sheath 4 is positionedwithin the catheter hub 2, the occluding device 100 can be advanced fromthe introducer sheath 4 into the catheter 1 in preparation for deployingthe occluding device 100 within the vasculature of the patient.

The catheter 1 may have at least one fluid introduction port 6 locatedadjacent the hub 2 or at another position along its length. The port 6is preferably in fluid communication with the distal end of the catheter1 so that a fluid, e.g., saline, may be passed through the catheter 1prior to insertion into the vasculature for flushing out air or debristrapped within the catheter 1 and any instruments, such as guidewires,positioned within the catheter 1. The port 6 may also be used to deliverdrugs or fluids within the vasculature as desired.

FIG. 45 illustrates the introducer sheath 4, an elongated flexibledelivery guidewire assembly 20 that is movable within the introducersheath 4 and the occluding device 100. As shown, the guidewire assembly20 and the occluding device 100, carried by the guidewire assembly 20,have not been introduced into the catheter 1. Instead, as illustrated,they are positioned within the introducer sheath 4. The introducersheath 4 may be made from various thermoplastics, e.g., PTFE, FEP, HDPE,PEEK, etc., which may optionally be lined on the inner surface of thesheath or an adjacent surface with a hydrophilic material such as PVP orsome other plastic coating. Additionally, either surface may be coatedwith various combinations of different materials, depending upon thedesired results.

The introducer sheath 4 may include drainage ports or purge holes (notshown) formed into the wall near the area covering the occluding device100. There may be a single hole or multiple holes, e.g., three holes,formed into introducer sheath 4. These purge holes allow for fluids,e.g., saline, to readily escape from in between the introducer sheath 4and the guidewire assembly 20 when purging the sheath prior topositioning the introducer sheath 4 in contact with the catheter hub 2,e.g., to remove trapped air or debris.

As shown in FIG. 46, the guidewire assembly 20 includes an elongatedflexible guidewire 41. The flexibility of the guidewire 41 allows theguidewire assembly 20 to bend and conform to the curvature of thevasculature as needed for positional movement of the occluding device100 within the vasculature. The guidewire 41 may be made of aconventional guidewire material and have a solid cross section.Alternatively, the guidewire 41 can be formed from a hypotube. In eitherembodiment, the guidewire 41 has a diameter D5 ranging from about 0.010inch to about 0.020 inch. In an embodiment, the largest diameter of theguidewire 41 is about 0.016 inch. The material used for the guidewire 41can be any of the known guidewire materials including superelasticmetals, e.g., Nitinol. Alternatively, the guidewire 41 can be formed ofmetals such as stainless steel. Length L4 of the guidewire can be fromabout 125 to about 190 cm. In an embodiment, the length L4 is about 175cm.

The guidewire assembly 20 can have the same degree of flexion along itsentire length. In an alternative embodiment, the guidewire assembly 20can have longitudinal sections, each with differing degrees offlexion/stiffness. The different degrees of flexions for the guidewireassembly 20 can be created using different materials and/or thicknesseswithin different longitudinal sections of the guidewire 41. In anotherembodiment, the flexion of the guidewire 41 can be controlled by spacedcuts (not shown) formed within the delivery guidewire 41. These cuts canbe longitudinally and/or circumferentially spaced from each other. Thecuts can be formed with precision within the delivery guidewire 41.Different sections of the delivery guidewire 41 can include cuts formedwith different spacing and different depths to provide these distinctsections with different amounts of flexion and stiffness. In any of theabove embodiments, the guidewire assembly 20 and the guidewire 41 areresponsive to torque applied to the guidewire assembly 20 by theoperator. As discussed below, the torque applied to the guidewireassembly 20 via the guidewire 41 can be used to release the occludingdevice 100 from the guidewire assembly 20.

The size and shape of the cuts formed within the delivery guidewire 41may be controlled so as to provide greater or lesser amounts offlexibility. Because the cuts can be varied in width without changingthe depth or overall shape of the cut, the flexibility of the deliveryguidewire 41 may be selectively altered without affecting the torsionalstrength of the delivery guidewire 41. Thus, the flexibility andtorsional strength of the delivery guidewire 41 may be selectively andindependently altered.

Advantageously, longitudinally adjacent pairs of cuts may be rotatedabout 90 degrees around the circumference of the delivery guidewire 41from one another to provide flexure laterally and vertically. However,the cuts may be located at predetermined locations to providepreferential flexure in one or more desired directions. Of course, thecuts could be randomly formed to allow bending (flexion) equally,non-preferentially in all directions or planes. In one embodiment, thiscould be achieved by circumferentially spacing the cuts.

The flexible delivery guidewire 41 can include any number of sectionshaving the same or differing degrees of flexion. For example, theflexible delivery guidewire 41 could include two or more sections. Inthe embodiment illustrated in FIG. 46, the flexible delivery guidewire41 includes three sections, each having a different diameter. Eachsection can have a diameter of about 0.003 inch to about 0.025 inch. Inan embodiment, the diameter of one or more sections can be about 0.010inch to about 0.020 inch. A first section 42 includes a proximal end 47that is located opposite the position of the occluding device 100. Thefirst section 42 can have a constant thickness along its length.Alternatively, the first section 42 can have a thickness (diameter) thattapers along its entire length or only a portion of its length. In thetapered embodiment, the thickness (diameter) of the first section 42decreases in the direction of a second, transition section 44. For thoseembodiments in which the guidewire 41 has a circular cross section, thethickness is the diameter of the section.

The second, transition section 44 extends between the first section 42and a third, distal section 46. The second section 44 tapers inthickness from the large diameter of the first section 42 to the smallerdiameter of the third section 46. As with the first section 42, thesecond section 44 can taper along its entire length or only a portion ofits length.

The third section 46 has a smaller thickness compared to the othersections 42, 44 of the delivery guidewire 41. The third section 46extends away from the tapered second section 44 that carries theoccluding device 100. The third section 46 can taper along its entirelength from the second section 44 to the distal end 27 of the deliveryguidewire 41. Alternatively, the third section 46 can have a constantdiameter or taper along only a portion of its length. In such anembodiment, the tapering portion of the third section 46 can extend fromthe second section 44 or a point spaced from the second section 44 to apoint spaced from distal end 27 of the delivery guidewire 41. Althoughthree sections of the delivery guidewire 41 are discussed andillustrated, the delivery guidewire 41 can include more than threesections. Additionally, each of these sections can taper in theirthickness (diameter) along all or only a portion of their length. In anyof the disclosed embodiments, the delivery guidewire 41 can be formed ofa shape memory alloy such as Nitinol.

A tip 28 and flexible tip coil 29 are secured to the distal end 27 ofthe delivery guidewire 41 as shown in FIGS. 46 and 47. The tip 28 caninclude a continuous end cap or cover as shown in the figures, whichsecurely receives a distal end of the tip coil 29. Flexion control isprovided to the distal end portion of the delivery guidewire 41 by thetip coil 29. However, in an embodiment, the tip 28 can be free of thecoil 29. The tip 28 has a non-percutaneous, atraumatic end face. In theillustrated embodiment, the tip 28 has a rounded face. In alternativeembodiments, the tip 28 can have other non-percutaneous shapes that willnot injure the vessel in which it is introduced. As illustrated in FIG.46, the tip 28 includes a housing 49 that securely receives the distalend of the guidewire 41 within an opening 48 in the interior surface ofthe housing 49. The guidewire 41 can be secured within the opening byany known means.

As shown in FIG. 46, the tip coil 29 surrounds a portion of theguidewire 41.

The tip coil 29 is flexible so that it will conform to and follow thepath of a vessel within the patient as the tip 28 is advanced along thevessel and the guidewire 41 bends to follow the tortuous path of thevasculature. The tip coil 29 extends rearward from the tip 28 in thedirection of the proximal end 47, as shown.

The tip 28 and coil 29 have an outer diameter D1 of about 0.010 inch toabout 0.018 inch. In an embodiment, their outer diameter D1 is about0.014 inch. The tip 28 and coil 29 also have a length L1 of about 0.1 cmto about 3.0 cm. In an embodiment, they have a total length L1 of about1.5 cm.

A proximal end 80 of the tip coil 29 is received within a housing 82 ata distal end 44 of a protective coil 85, as shown in FIGS. 43 and 46.The housing 82 and protective coil 85 have an outer diameter D2 of about0.018 inch to about 0.038 inch. In an embodiment, their outer diameterD2 is about 0.024 inch. The housing 82 and protective coil 85 have alength L2 of about 0.05 cm to about 0.2 cm. In an embodiment, theirtotal length L2 is about 0.15 cm.

The housing 82 has a non-percutaneous, atraumatic shape. For example, asshown in FIG. 47, the housing 82 has a substantially blunt profile.Also, the housing 82 can be sized to open/support the vessel as itpasses through it. Additionally, the housing 82 can include angledsidewalls sized to just be spaced just off the inner surface of theintroducer sheath 4.

The housing 82 and protective coil 85 form a distal retaining memberthat maintains the position of the occluding device 100 on the flexibleguidewire assembly 20 and helps to hold the occluding device 100 in acompressed state prior to its delivery and deployment within a vessel ofthe vasculature. The protective coil 85 extends from the housing 82 inthe direction of the proximal end 47 of the delivery guidewire 41, asshown in FIG. 46. The protective coil 85 is secured to the housing 82 inany known manner. In a first embodiment, the protective coil 85 can besecured to the outer surface of the housing 82. In an alternativeembodiment, the protective coil 85 can be secured within an opening ofthe housing 82 so that the housing 82 surrounds and internally receivesthe distal end 51 of the protective coil 85 (FIG. 46). As shown in FIGS.45 and 46, the distal end 102 of the occluding device 100 is retainedwithin the proximal end 52 so that the occluding device 100 cannotdeploy while positioned in the sheath 4 or the catheter 1.

At the proximal end of the occluding device 100, a bumper coil 86 andcap 88 prevent or limit lateral movement of the occluding device 100along the length of the guidewire 41 in the direction of the proximalend 47, see FIG. 45. The bumper coil 86 and cap 88 have an outerdiameter D4 of about 0.018 inch to about 0.038 inch. In an embodiment,their outer diameter D4 is about 0.024 inch. The cap 88 contacts theproximal end 107 of the occluding device 100 and prevents or limits itfrom moving along the length of the guidewire 41 away from theprotective coil 85. The bumper coil 86 can be in the form of a springthat contacts and pressures the cap 88 in the direction of theprotective coil 85, thereby creating a biasing force against theoccluding device 100. This biasing force (pressure) aids in maintainingthe secured, covered relationship between the distal end 102 of theoccluding device 100 and the protective coil 85. As with any of thecoils positioned along the delivery guidewire 41, the bumper coil 86 canbe secured to the delivery guidewire 41 by soldering, welding, RFwelding, glue, and/or other known adhesives.

In an alternative embodiment illustrated in FIG. 52, the bumper coil 86is not utilized. Instead, a proximal end 107 of the occluding device 100is held in position by a set of spring loaded arms (jaws) 104 whilepositioned within the introducer sheath 4 or the catheter 1. The innersurfaces of the catheter 1 and the introducer sheath 4 limit the radialexpansion of the arms 104. When the proximal end of the occluding devicepasses out of the catheter 1, the arms 104 would spring open and releasethe occluding device as shown in FIG. 53.

In another example, the occluding device 100 in the introducer sheath 4or the catheter 1 may expand within a vessel under pressure. FIG. 54illustrates an example of an expanded occluding device 100 that expandsresponsive to pressure. Pressure may be applied through the catheter 1or the introducer sheath 4 as the occluding device 100 passes out of thecatheter 1. The pressure may be exerted through application of air,fluid, or any material for increasing the internal pressure of theoccluding device. The increase in pressure within the occluding device100 when the occluding device 100 passes out of the catheter 1 may causethe occluding device to expand within the vessel. Conversely, a negativepressure may be exerted at the occluding device 100. FIG. 55 illustratesthe occluding device 100 of FIG. 54 after a negative pressure is appliedto the occluding device 100. The negative pressure may be applied viathe catheter 1 or the introducer sheath 4 and may cause the occludingdevice 100 to retract or decrease in size. In one example, a negativepressure is exerted at the occluding device 100 after the occludingdevice 100 is passed out of the catheter 1 and expanded in the vessel.The negative pressure causes the occluding device 100 to retract. Uponretraction, the occluding device 100 may be reduced in size. In anotherexample, the occluding device 100 may be replaced back into the catheter1 after retraction. The negative pressure may be applied in a variety ofways. For example, the negative pressure may be applied by suction ofair from the catheter 1 or by removal or suction of fluid from thecatheter 1.

Also, in another example, the occluding device 100 may be expanded, forexample, by application of increased pressure within the occludingdevice. The increased pressure may be administered via the deliverydevice by, for example, injecting air or fluid via the delivery deviceto the occluding device 100. The occluding device 100 may thus beexpanded in a vessel such that the occluding device 100 may come intocontact with the internal aspect of the wall of the vessel. In this way,at least a portion of the occluding device 100, while in the expandedstate, may contact the wall of the vessel.

While in the expanded state, the occluding device 100 may berepositioned within the vessel. FIG. 60 illustrates an example of anexpanded occluding device 100. FIG. 61 illustrates the example of FIG.60 after the occluding device is repositioned within a blood vessel. Inthis example, the occluding device 100 may be expanded in a longitudinalaxis along the vessel such that the occluding device 100 may move withinthe vessel while expanded. Pressure may be exerted by a user at aproximal end of the occluding device 100 such that the proximal end ismoved distally within the vessel lumen. At the same time, frictionalforces between the wall of the vessel and the more distal portions ofthe occluding device may prevent or limit immediate movement of the moredistal portions of the occluding device. When the pressure or forceexerted at the proximal end exceeds a threshold level, the force may betransmitted to the more distal portions of the occluding device to causethe more distal portions of the occluding device to more distally in thelumen of the vessel. In this way, the occluding device may move distallyin the vessel lumen and may be repositioned at a desired location withinthe vessel by the user. FIG. 61 illustrates distal repositioning of theoccluding device in a blood vessel.

Similarly, the occluding device may be repositioned more proximally inthe vessel lumen by the user. For example, the user may provide a forceor pressure at a distal portion of the occluding device in a proximaldirection. The distal portion of the occluding device may moveproximally while frictional forces between the more proximal portions ofthe occluding device prevent or limit initial movement of the moreproximal portions of the occluding device. Hence, in this example, theoccluding device compresses at a portion intermediate between the distalportion and the more proximal portions of the occluding device. When thepressure or force exerted by the user at the distal portion of theoccluding device exceeds a threshold level that exceeds the frictionalforce preventing or limiting movement of the more proximal portions ofthe occluding device, the more proximal portions of the occluding devicemay move in a proximal direction responsive to the applied pressure orforce. In this way, the occluding device may be repositioned proximallyin the vessel.

In another example, the occluding device 100 may be repositioned in ablood vessel while the occluding device 100 is in a retracted state.FIG. 62 illustrates an example of the occluding device 100 in aretracted state. For example, negative pressure may be exerted at theoccluding device 100 of FIG. 54 to cause the occluding device 100 todecrease in size as illustrated in FIG. 62. The occluding device 100 asillustrated in FIG. 62 is retracted and approximates the deliverydevice. FIG. 63 illustrates an example of repositioning the occludingdevice 100 while the occluding device is retracted. As FIG. 63illustrates, the occluding device is moved in a distal direction.Similarly, the occluding device may also be repositioned in a proximaldirection (not shown).

Also, deployment of the occluding device may be performed in parts. Forexample, the occluding device 100 may have a distal end and a proximalend. Deployment of the occluding device may include release of a distalend followed by release of the proximal end of the occluding device.Alternatively, deployment of the occluding device may include release ofthe proximal end followed by release of the distal end. Also, deploymentof the occluding device may include release of the proximal end and thedistal end of the occluding device 100 at approximately the same time.

FIG. 56 illustrates an example of release of the distal end of theoccluding device 100 while the proximal end of the occluding deviceremains attached to the delivery device. As FIG. 56 shows, the distalend of the occluding device 100 is deployed and abuts the wall of theblood vessel. The proximal end of the occluding device 100 is stillattached to the delivery device. Release of the proximal end of theoccluding device may be accomplished in a variety of ways as describedherein.

In addition, the partially deployed occluding device 100 as illustratedin FIG. 56 may be repositioned in the blood vessel. FIG. 57 illustratesan example of a partially deployed occluding device 100 in which thedistal end of the occluding device 100 has been released from thedelivery device while the proximal end of the occluding device 100remains attached and non-deployed to the delivery device. In addition,FIG. 57 demonstrates repositioning of the occluding device whilepartially deployed. As FIG. 57 shows, the delivery device and occludingdevice 100 has been moved proximally in the blood vessel. Also, FIG. 57illustrates that the occluding device is partially deployed in the bloodvessel such that the distal end of the occluding device is released fromthe delivery device while the proximal end of the occluding device 100remains attached to the delivery device.

As shown in FIGS. 56 and 57, the proximal end of the occluding device100 remains in a compressed configuration while the rest of theoccluding device 100 is in the expanded configuration. In addition torepositioning the occluding device 100, the porosity of any portion ofthe occluding device 100 may be decreased by applying a longitudinallycompressive force to the occluding device 100, for example by advancingthe proximal end of the occluding device 100 towards the distal end ofthe occluding device 100 such that the middle portions of the occludingdevice 100 are longitudinally compressed. In one example, alongitudinally compressive force may be applied to the proximal end ofthe occluding device 100 where the longitudinally compressive force isgreater than a frictional force between the contact of a first portion111 of the occluding device 100 and the vessel wall. The axiallycompressive force may continue to be applied such that a second portion112 of the occluding device 100 is longitudinally compressed, resultingin a decrease in porosity. Note that the second portion 112 issubstantially adjacent to the aneurysm A, which presents less frictionalforce between the contact of the second portion 112 of the occludingdevice 100 and the surrounding vessel wall.

Additionally, the porosity of any portion of the occluding device 100may be increased by applying a longitudinally expansive force to theoccluding device 100, for example by withdrawing the proximal end of theoccluding device 100 away from the distal end of the occluding device100 such that the middle portions of the occluding device 100 arelongitudinally expanded. For example, a longitudinally expansive forcemay be applied to the proximal end of the occluding device 100 where thelongitudinally expansive force is greater than a frictional forcebetween the contact of the first portion 111 of the occluding device 100and the vessel wall. The longitudinally expansive force may continue tobe applied such that the second portion 112 of the occluding device 100is longitudinally expanded, resulting in an increase in porosity. Thus,the porosity of the second portion 112 of the occluding device 100 maybe increased by withdrawing the proximal end of the occluding device 100away from the distal end of the occluding device 100. The porosity ofany portion of the occluding device 100 may be adjusted similarly byadvancing or withdrawing the occluding device 100.

The occluding device 100 may also be retracted or removed from thevessel by withdrawing the proximal end of the occluding device 100,which remains attached to the delivery device, into the catheter 1. Bycontinually withdrawing the proximal end of the occluding device 100into the catheter 1, any expanded portions of the occluding device 100may be drawn into the catheter 1 and compressed such that the occludingdevice 100 may fit within the catheter 1.

Alternatively, the proximal end of the occluding device may be releasedfrom the delivery device while the distal end of the occluding deviceremains attached to the delivery device. The distal end of the occludingdevice may then be deployed or released from the delivery device at asubsequent time. FIG. 58 illustrates an example of a partially deployedoccluding device 100 in a blood vessel in which the proximal end of theoccluding device 100 is released from the delivery device while thedistal end of the occluding device remains attached to the deliverydevice. The proximal end of the occluding device 100 thus approximatesthe walls of the blood vessel.

FIG. 59 illustrates the example of FIG. 58 in which the occluding device100 is repositioned proximally in the blood vessel. In this example, theoccluding device is partially deployed such that the proximal end of theoccluding device 100 is released from the delivery device while thedistal end of the occluding device 100 is attached. The occluding deviceis then moved or repositioned to a more proximal location within theblood vessel. Alternatively, the occluding device may also be moved orrepositioned to a more distal location within the blood vessel (notshown).

As shown in FIGS. 58 and 59, the distal end of the occluding device 100remains in a compressed configuration while the rest of the occludingdevice 100 is in the expanded configuration. In addition torepositioning the occluding device 100, the porosity of any portion ofthe occluding device 100 may be decreased by applying a longitudinallycompressive force to the occluding device 100, for example bywithdrawing the distal end of the occluding device 100 towards theproximal end of the occluding device 100 such that the middle portionsof the occluding device 100 are longitudinally compressed. In oneexample, a longitudinally compressive force may be applied to the distalend of the occluding device 100 where the longitudinally compressiveforce is greater than a frictional force between the contact of a firstportion 115 of the occluding device 100 and the vessel wall. Thelongitudinally compressive force may continue to be applied such that asecond portion 116 of the occluding device 100 is longitudinallycompressed, resulting in a decrease in porosity. Note that the secondportion 116 is substantially adjacent to the aneurysm A, which presentsless frictional force between the contact of the second portion 116 ofthe occluding device 100 and the surrounding vessel wall.

Additionally, the porosity of any portion of the occluding device 100may be increased by applying a longitudinally expansive force to theoccluding device 100, for example by advancing the distal end of theoccluding device 100 away from the proximal end of the occluding device100 such that the middle portions of the occluding device 100 arelongitudinally expanded. For example, a longitudinally expansive forcemay be applied to the distal end of the occluding device 100 where thelongitudinally expansive force is greater than a frictional forcebetween the contact of the first portion 115 of the occluding device 100and the vessel wall. The longitudinally expansive force may continue tobe applied such that the second portion 116 of the occluding device 100is longitudinally expanded, resulting in an increase in porosity. Thus,the porosity of the second portion 116 of the occluding device 100 maybe increased by advancing the distal end of the occluding device 100away from the proximal end of the occluding device 100. The porosity ofany portion of the occluding device 100 may be adjusted similarly byadvancing or withdrawing the occluding device 100 relative to theproximal end of the occluding device 100.

In an alternative embodiment, the bumper coil 86 and cap 88 can beeliminated and the proximal end of the occluding device 100 can be heldin position relative to the protective coil 85 by a tapered section ofthe guidewire 41. In such an embodiment, the enlarged cross section ofthis tapered section can be used to retain the occluding device 100 inposition along the length of the delivery guidewire 41 and prevent orlimit movement of the occluding device 100 in the direction of theproximal end 47.

As shown in FIG. 46, the guidewire assembly 20 includes a support 70 forthe occluding device 100. In a first embodiment, the support 70 caninclude an outer surface of the delivery guidewire 41 that is sized tocontact the inner surface of the occluding device 100 when the occludingdevice 100 is loaded on the guidewire assembly 20. In this embodiment,the outer surface of the delivery guidewire 41 supports the occludingdevice 100 and maintains it in a ready to deploy state. In anotherembodiment, illustrated in the Figures, the support 70 comprises amid-coil 70 that extends from a location proximate the protective coil85 rearward toward the bumper coil 86. The mid-coil 70 extends under theoccluding device 100 and over the delivery guidewire 41, as shown inFIG. 43. The mid-coil 70 can be coextensive with one or more sections ofthe delivery guidewire 41. For example, the mid-coil 70 could becoextensive with only the second section 44 of the delivery guidewire 41or it could extend along portions of both the third section 46 and thesecond section 44 of the delivery guidewire 41.

The mid-coil 70 provides the guidewire assembly 20 with an outwardlyextending surface that is sized to contact the inner surface of theoccluding device 100 in order to assist in supporting the occludingdevice and maintaining the occluding device 100 in a ready to deploystate. Like the other coils discussed herein and illustrated in thefigures, the coiled form of the mid-coil 70 permits the mid-coil 70 toflex with the delivery guidewire 41 as the delivery guidewire 41 isadvanced through the vasculature of the patient. The mid-coil 70provides a constant diameter along a length of the delivery guidewire 41that is covered by the occluding device 100 regardless of the taper ofthe delivery guidewire 41 beneath the occluding device 100. The mid-coil70 permits the delivery guidewire 41 to be tapered so it can achieve theneeded flexibility to follow the path of the vasculature withoutcompromising the support provided to the occluding device 100. Themid-coil 70 provides the occluding device 100 with constant supportregardless of the taper of the delivery guidewire 41 prior to theoccluding device 100 being deployed. The smallest diameter of theoccluding device 100 when in its compressed state is also controlled bythe size of the mid-coil 70. Additionally, the diameter of the mid-coil70 can be chosen so that the proper spacing, including no spacing, isestablished between the occluding device 100 and the inner wall of thecatheter 1 prior to deployment of the occluding device 100. The mid-coil70 can also be used to bias the occluding device 100 away from thedelivery guidewire 41 during its deployment.

In either embodiment, the support 70 can have an outer diameter D3 ofabout 0.010 inch to about 0.018 inch. In an embodiment, the outerdiameter D3 is about 0.014 inch. The support 70 can also have a lengthL3 of about 2.0 cm to about 30 cm. In an embodiment, the length L3 ofthe support 70 is about 7 cm.

The occluding device 100 may also be placed on the mid-coil 70 betweenan optional pair of radio-opaque marker bands located along the lengthof the guidewire assembly 20. Alternatively, the protective coil 85,bumper coil 86 and or mid-coil 70 can include radio-opaque markers. Inan alternative embodiment, the guidewire assembly 20 may include only asingle radio-opaque marker. The use of radio-opaque markers allows forthe visualization of the guidewire assembly 20 and the occluding device100 during placement within the vasculature. Such visualizationtechniques may include conventional methods such as fluoroscopy,radiography, ultra-sonography, magnetic resonance imaging, etc.

The occluding device 100 can be delivered and deployed at the site of ananeurysm according to the following method and variations thereof. Thedelivery of the occluding device 100 includes introducing the catheter 1into the vasculature until it reaches a site that requires treatment.The catheter 1 is introduced into the vasculature using a conventionaltechnique such as being advanced over or simultaneously with aconventional vascular guidewire (not shown). The positioning of thecatheter 1 can occur before it receives the guidewire assembly 20 orwhile it contains the guidewire assembly 20. The position of thecatheter 1 within the vasculature can be determined by identifyingradio-opaque markers positioned on or in the catheter 1.

After the catheter 1 is positioned at the desired location, theguidewire is removed and the distal end of the introducer sheath 4 isinserted into the proximal end of the catheter 1, as shown in FIG. 43.In an embodiment, the distal end of the introducer sheath 4 isintroduced through the hub 2 at the proximal end of the catheter 1. Theintroducer sheath 4 is advanced within the catheter 1 until a distal tipof the introducer sheath 4 is wedged within the catheter 1. At thisposition, the introducer sheath 4 cannot be advanced further within thecatheter 1. The introducer sheath 4 is then securely held while thedelivery guidewire assembly 20 carrying the occluding device 100 isadvanced through the introducer sheath 4 until the occluding device 100is advanced out of the introducer sheath 4 and into the catheter 1.

The guidewire assembly 20 and the occluding device 100 are advancedthrough the catheter 1 until the tip coil 29 is proximate the distal endof the catheter 1. At this point, the position of the catheter 1 andguidewire assembly 20 can be confirmed. The guidewire assembly 20 isthen advanced out of the catheter 1 and into the vasculature of thepatient so that the proximal end 107 of the occluding device 100 ispositioned outside the distal end of the catheter 1 and adjacent thearea to be treated. At any point during these steps, the position of theoccluding device 100 can be checked to determine that it will bedeployed correctly and at the desired location. This can be accomplishedby using the radio-opaque markers discussed above.

When the distal end 102 of the occluding device 100 is positionedoutside the catheter 1, the proximal end 107 will begin to expand, inthe direction of the arrows shown in FIG. 49, within the vasculaturewhile the distal end 102 remains covered by the protective coil 85. Whenthe occluding device 100 is in the proper position, the deliveryguidewire 41 is rotated (See FIG. 50) until the distal end 102 of theoccluding device 100 moves away from the protective coil 85 and expandswithin the vasculature at the desired location. The delivery guidewire41 can be rotated either clockwise or counter clockwise as needed todeploy the occluding device 100. In an embodiment, the deliveryguidewire 41 may be rotated, for example, between about two and tenturns in either or both directions. In another example, the occludingdevice may be deployed by rotating the delivery guidewire 41 clockwisefor less than about five turns, for example, three to five turns. Afterthe occluding device 100 has been deployed, the delivery guidewire 41can be retracted into the catheter 1 and removed from the body.

In one alternative or additional deployment method, the distal end 102of the occluding device 100 may be passed outside of the catheter 1. Theoccluding device 100 may be further advanced so that the proximal end107 of the occluding device 100 passes outside of the catheter. However,in this example, the proximal end 107 of the occluding device 100expands responsive to the application of pressure to the inner surfacesof the occluding device 100. The applied pressure may be from anysource. Examples of pressure exerted in the occluding device 100include, but are not limited to, infusion of fluid or air into the lumenof the occluding device.

The increase in pressure in the occluding device may cause the occludingdevice 100 to expand. Expansion of the occluding device 100 may cause adisconnection of the proximal end 107 of the occluding device 100 and/orthe distal end 102 of the occluding device 100 such that the occludingdevice may substantially fill the lumen of the vessel. Alternatively,the increase in pressure in the occluding device may expand theoccluding device 100 without detachment of either the proximal end 107or the distal end 102 of the occluding device 100. In this example, theoccluding device 100 may be expanded without detaching the occludingdevice 100 from the delivery system. The expanded occluding device 100may be adjusted and moved within the vessel in the expanded state whileconnected to the delivery system. When the occluding device 100 is at adesired location in the vessel, the occluding device 100 may be releasedfrom the delivery system. Release of the occluding device 100 from thedelivery system may be accomplished in a variety of ways as describedherein.

In addition, the coverage of the occluding device 100 may be adjustedwhile the occluding device is expanded and connected to the deliverysystem. For example, the occluding device 100 may be unsheathed from thecatheter 1 and expanded under pressure (e.g., from fluid or air) suchthat the occluding device 100 is expanded in the vessel. The position ofthe occluding device 100 may be further adjusted. Also, the pressureapplied within the occluding device 100 may be adjusted to increase thesize of the expanded occluding device 100 in the vessel. Relativeadjustments of the size of the expanded occluding device 100 (i.e., byadjusting the amount of pressure applied to the occluding device 100)and of the position or location of the occluding device 100 permitcontrol of coverage of the occluding device when placed in the vessel.

Also, a negative pressure may be applied (e.g., air suction or removalof fluid from within the occluding device 100) to cause the occludingdevice to retract. The retracted occluding device 100 may further beplaced back into the catheter 1. In one example, the occluding device100 may be expanded and retracted as desired for movement or placementof the occluding device 100 within the vessel.

In an alternative or additional deployment step shown in FIG. 51,friction between the occluding device 100 and inner surface of thecatheter 1 cause the distal end of the occluding device 100 to separatefrom the protective coil 85. The friction can be created by the openingof the occluding device 100 and/or the mid-coil 70 biasing the occludingdevice 100 toward the inner surface of the catheter 1. The frictionbetween the catheter 1 and the occluding device 100 will assist in thedeployment of the occluding device 100. In those instances when theoccluding device 100 does not open and separate from the protective coil85 during deployment, the friction between occluding device 100 and theinner surface of the catheter 1 will cause the occluding device 100 tomove away from the protective coil 85 as the delivery guidewire 41 andthe catheter 1 move relative to each other. The delivery guidewire 41can then be rotated and the occluding device 100 deployed within thevessel.

After the occluding device 100 radially self-expands into gentle, butsecure, contact with the walls of the vessel so as to occlude the neckof the aneurysm A, the catheter 1 may be removed entirely from the bodyof the patient. Alternatively, the catheter 1 may be left in positionwithin vasculature to allow for the insertion of additional tools or theapplication of drugs near the treatment site.

Known materials can be used in the subject technology. One commonmaterial that can be used with the occluding device 100 and theguidewire 41 is Nitinol, a nickel-titanium shape memory alloy, which canbe formed and annealed, deformed at a low temperature, and recalled toits original shape with heating, such as when deployed at bodytemperature in the body. The radio-opaque markers can be formed ofradio-opaque materials including metals, such as platinum, or dopedplastics including bismuth or tungsten to aid in visualization.

Methods of Implantation and Monitoring

In some embodiments, a method of implantation and monitoring can be usedfor example with the deployment systems described above. The method caninclude implanting an occluding device within the vasculature of apatient such that the device extends, within and along a vessel, past ananeurysm. Example occluding devices, deployment devices, microcathetersfor delivery of occluding devices, and deployment methods are describedin U.S. Provisional Application No. 60/574,429, filed on May 25, 2004;U.S. patent application Ser. No. 11/136,395 (U.S. Patent ApplicationPublication No. 2005/0267568), filed on May 25, 2005; U.S. patentapplication Ser. No. 11/420,025 (U.S. Patent Application Publication No.2006/0206200), filed on May 24, 2006; U.S. patent application Ser. No.11/420,027 (U.S. Patent Application Publication No. 2006/0206201), filedon May 24, 2006; U.S. patent application Ser. No. 11/136,398 (U.S.Patent Application Publication No. 2006/0271149), filed on May 25, 2005;U.S. patent application Ser. No. 11/420,023 (U.S. Patent ApplicationPublication No. 2006/0271153), filed on May 24, 2006; U.S. patentapplication Ser. No. 12/490,285 (U.S. Patent Application Publication No.2009/0318947), filed on Jun. 23, 2010; U.S. patent application Ser. No.12/425,604 (U.S. Patent Publication No. 2009/0287288), filed on Apr. 17,2009; U.S. patent application Ser. No. 12/425,617 (U.S. PatentApplication Publication No. 2009/0287241), filed on Apr. 17, 2009; U.S.patent application Ser. No. 12/431,716 (U.S. Patent ApplicationPublication No. 2009/0270974), filed on Apr. 28, 2009; U.S. patentapplication Ser. No. 12/431,717, filed on Apr. 28, 2009; U.S. patentapplication Ser. No. 12/431,721 (U.S. Patent Publication No.2009/0292348), filed on Apr. 28, 2009; U.S. patent application Ser. No.12/490,285 (U.S. Patent Application Publication No. 2010/0010624), filedon Jun. 23, 2009; U.S. patent application Ser. No. 12/490,285 (U.S.Patent Publication No. 2009/0319017), filed on Jun. 23, 2009; and U.S.patent application Ser. No. 12/731,110, filed on Mar. 24, 2010; each ofwhich is incorporated herein by reference in its entirety. Otheroccluding devices, deployment devices, catheters, and deployment methodsare also possible.

In some embodiments, the method includes monitoring the aneurysmpost-operatively to confirm occlusion of the aneurysm. In someembodiments, a doctor or other provider may determine that an occludingdevice, after implantation, is operating correctly based on observationthat full or partial occlusion of the aneurysm has occurred, for exampleusing the observation and/or determination techniques described herein.

According to certain embodiments, observation of at least partialocclusion of the aneurysm immediately after implantation of theoccluding device provides an indication that the occluding device isoperating correctly. As a result, prolonged monitoring of the patientafter implantation of the occluding device may not be necessary. In someembodiments, monitoring the aneurysm can include imaging the aneurysmthrough known imaging techniques to confirm that the aneurysm iscompletely or at least partially occluded. For example, imagingtechniques such as those utilizing fluoroscopy, CAT scans, X-rays, MRIs,or other suitable imaging techniques may be used to monitor theaneurysm.

In some embodiments, two-dimensional imaging is utilized to monitor theaneurysm during and/or after delivery of the device within the vessel.In some embodiments, three-dimensional imaging is utilized to monitorthe aneurysm. For example, imaging of the delivery can be monitoredduring advancement of the device in the vasculature, deployment of thedevice at the aneurysm, and after deployment of the device prior toinitiation of withdrawal of the delivery system. In some embodiments,contrast agent can be delivered during advancement of the device in thevasculature, deployment of the device at the aneurysm, and/or afterdeployment of the device prior to initiation of withdrawal of thedelivery system. The contrast agent can be delivered through the samecatheter used to deliver the occluding device, or through anothercatheter or device commonly used to delivery contrast agent. Forexample, the catheter may comprise a lumen extending from a positionoutside the patient to a position proximate to the site to be treated(e.g., via a Y-joint in a handle of the catheter), and the lumen can beused to deliver contrast agent, drugs, saline, etc. In certain suchembodiments, the lumen may be coaxial with the delivery lumen,side-by-side the delivery lumen, etc. In some embodiments, initiation ofwithdrawal of the delivery system can be based on results from imagingthe device and aneurysm following expansion of the device at theaneurysm. Is some embodiments, the results obtained from the imaginginclude partial occlusion of the aneurysm, which results then provideindication that the device is promoting occlusion of the aneurysm.

Although rare, in some instances, occlusion may not occur with thedeployment of a single occluding device. In certain such instances,monitoring of the aneurysm and device following deployment of theoccluding device at the aneurysm can indicate whether partial occlusionis occurring. If partial occlusion does not occur, some embodimentsprovide for deployment of a second device within the first device tofurther promote occlusion within the aneurysm. Regardless of whether oneor multiple devices are deployed, upon confirmation that partialocclusion is occurring within the aneurysm, withdrawal of the deliverysystem can be initiated.

In some embodiments, other techniques may be used to determine whetherat least partial occlusion of the aneurysm has occurred. For example,blood flow into an aneurysm may be monitored after positioning of thedevice within the vessel to determine whether occlusion is occurring.Reduced blood flow into an aneurysm may be an indication that occlusionof the aneurysm is occurring. In some embodiments, radiopaque markers orother suitable trackers may be used to enable or enhance the monitoringof the blood flow into an aneurysm. In some embodiments, the pressure ofthe blood flow into an aneurysm, or the pressure exerted on the walls ofthe aneurysm may be monitored to determine if occlusion of the aneurysmis occurring. For example, reduced outward pressure being exerted on thewalls of the aneurysm as determined from blood flow patterns in thevessel distal to the aneurysm measured by an endovascular transducer mayindicate that at least partial occlusion is occurring. In someembodiments, the stiffness or the hardness of the aneurysm may bemeasured to determine whether occlusion is occurring. For example,occlusion of the aneurysm may occur, leading to at least partialthrombosis within the aneurysm. As a result, the aneurysm may be stifferor harder, for example determined by observing variance in pulsation,than it would have been had occlusion not occurred.

In some embodiments, the method provides that one or more deliverydevices, which assist in the deployment of the occluding device withinthe vessel, remain in place within the patient until confirmation ofcomplete or partial occlusion of the aneurysm. FIGS. 83A-84E illustrateexamples of various types of images that may be utilized in order todetermine whether an aneurysm 10 has been or is being occluded, inaccordance with certain embodiments. For example, a doctor or otherprovider may confirm that occlusion of the aneurysm 10 has occurred byobserving that at a stagnated area, region, or portion 77 of fluid flowhas formed within the aneurysm 10. The stagnated area 77 may form invarious areas within aneurysm 10, for example as illustrated in FIGS.83A-83E and 84A-84E.

Depending on the imaging technique (e.g., fluoroscopy), indication ofthe stagnated area 77 can be provided in many ways. In two dimensionalimaging, the image may reflect only a slice or elevational view of theaneurysm 10. As such, it is possible that a stagnated area 77 has formedin the aneurysm 10, but the stagnated area 77 may not be apparent in theslice because the image slice does not transect the stagnated area 77within the aneurysm 10. Additionally, the cross-section or elevationalview of the stagnated area 77 may take on different shapes depending onhow the image is observed. Accordingly, some embodiments comprise takinga plurality of images of the aneurysm 10 for determining an amount ofstagnated area 77. In some embodiments, a cross-sectional slicesubstantially central to the aneurysm 10 can be viewed to determine ageneral amount of stagnation in the aneurysm 10.

The porosity of an occluding device can affect the amount of stagnationin the aneurysm 10. For example, a non-porous occluding device (e.g., anoccluding device devoid of or substantially devoid of pores) deployedacross the neck of an aneurysm 10 will at least theoretically block allfluid flow into the aneurysm 10, resulting in complete stagnation offluid flow in the aneurysm 10 (e.g., because there is no fluid flow toflush contrast agent out of the aneurysm 10). By contrast, a highlyporous occluding device (e.g., an occluding device with a large quantityand/or size of pores) deployed across the neck of an aneurysm 10 will atleast theoretically allow nearly unimpeded fluid flow into the aneurysm10, resulting in very little stagnation of fluid flow in the aneurysm 10and little to no stagnated area 77 (e.g., because the continuous fluidflow can flush contrast agent out of the aneurysm 10). Although theratio of porosity of the occluding device to stagnated area 77 is notbelieved to be 1:1 (e.g., 30% porosity resulting in 70% stagnation), areduction in porosity generally results in greater stagnation.

In some embodiments in which contrast agent is flowing through thevessel during deployment of the occluding device such that the contrastagent is able to circulate through the aneurysm 10 commensurate withfluid flow through the aneurysm 10 (e.g., intermittently), completestagnation of fluid flow inside an aneurysm 10 may result in a stagnatedarea 77 having a shape substantially equal to the shape of the inside ofthe aneurysm 10 (e.g., being substantially spherical). As describedherein, complete occlusion may disadvantageously also restrict bloodflow to branch vessels, so porous occluding devices are preferred. Insome embodiments in which contrast agent is flowing through the vesselduring deployment of the occluding device such that the contrast agentis able to circulate through the aneurysm 10 commensurate with fluidflow through the aneurysm 10 (e.g., intermittently), partial stagnationof fluid flow inside an aneurysm 10 may result in a stagnated area 77having a shape that is less than substantially equal to the shape of theinside of the aneurysm 10. For example, the stagnated area 77 may have acrescent shape extending from the neck of the aneurysm 10 towards theapex of the aneurysm 10 (e.g., extending from the circumference of theneck of the aneurysm 10 and becoming thicker towards the apex of theaneurysm 10). In some experiences, a crescent shape has been empiricallyknown to result in curing of the aneurysm 10 during patient follow up.For additional examples, the stagnated area 77 may have a mushroomshape, a hemispherical shape, and/or a flat side. In certainembodiments, identification of a shape of the stagnated area 77 may besufficient to determine that occlusion of the aneurysm 10 is sufficientto cause thrombosis within the aneurysm 10. In some embodiments, anyshape of contrast agent that persists in the aneurysm 10 (e.g., forgreater than 2 seconds, greater than 5 seconds, greater than 10 seconds,greater than 30 seconds, or more) may be indicative of suitableocclusion of the aneurysm 10. In certain embodiments, the identificationof an area or volume of the stagnated area 77 may be sufficient todetermine that occlusion of the aneurysm 10 is sufficient to causethrombosis within the aneurysm 10. In certain embodiments, theidentification of a shape of the stagnated area 77 in combination withthe identification of an area or volume of the stagnated area 77 may besufficient to determine that occlusion of the aneurysm 10 is sufficientto cause thrombosis within the aneurysm 10.

In some embodiments, stagnated area 77 may be visible because of alighter or darker shade of color shown, as a result of the contrastagent. The coloring or shading of the stagnated area 77 depends, forexample, upon the imaging technique utilized, and in some instances, thestagnation may be visible as a lighter shade in contrast to the adjacenttissue or fluids. In some embodiments, the stagnated area 77 may bevisible because blood flow 3 does not go through the stagnated area 77.In another example, a doctor or other provider may observe whether bloodflow 3 into the aneurysm 10 is being reduced, which may indicate that atleast partial occlusion of the aneurysm 10 is occurring. FIGS. 83A-83Dand 84A-84E illustrate two-dimensional imaging in order to confirm atleast partial occlusion of the aneurysm 10, although three-dimensionalimaging, such as in FIG. 83E, may be utilized as well.

In some embodiments, the stagnated area 77 in which the contrast agenthas settled indicates the portion of the aneurysm 10 in which a thrombusis most likely to form first. For example, in a two-month follow up, thestagnated area 77 may have thrombosed while other portions of theaneurysm 10 remain patent. Thus, the larger the stagnation area 77 (orpercentage occlusion) in the aneurysm 10, the larger the thrombus thatis likely to initially form in the aneurysm 10.

Depending on the imaging technique, it may be advantageous, in someinstances (e.g., two-dimensional imaging), to represent the amount ofstagnation or occlusion as a percentage of stagnated area 77. Thestagnated area 77 may be useful in embodiments that use a slice orcross-sectional view or an elevational view of the aneurysm 10. Incertain such embodiments, the stagnated area 77 may be determined by thearea of the cross-section or elevational view of the stagnated area 77.An aneurysm treatment area may be defined by the area in the slice orcross-sectional view or elevational view that is enclosed by the innerwall of the aneurysm 10 and the outer surface of the occluding devicewhen deployed. The percentage of stagnated area 77 can be calculated orvisually estimating by comparing the degree to which the aneurysmtreatment area is filled by the stagnated contrast agent. In someembodiments, the percentage of stagnation is used to determine when toinitiate withdrawal of the occlusion device delivery system.

In some embodiments, partial occlusion can be represented as avolumetric percentage of a treatment volume defined by the volumeenclosed by the inner wall of the aneurysm 10 and the outer surface ofthe deployed occlusion device. In this instance, the volume of thestagnated area 77 can be compared to the treatment volume, and thepercentage of the treatment volume that is filled by the volume ofstagnated area 77 can be represented as the volumetric stagnationpercentage. In some embodiments, this volumetric stagnation percentageis used to determine when to initiate withdrawal of the occlusion devicedelivery system. Because the percentage of occlusion can be representedin either volumetric percentages or area percentages, this descriptionwill refer to both percentages hereinafter generically as percentage.

In some embodiments, the occlusion device delivery system may remainwithin the patient until images of the aneurysm 10, or use of any of theother foregoing described techniques, are used to determine an amount ofocclusion of the aneurysm 10, for example by a desired percentage or theidentification of a certain shape, at which point, withdrawal of theocclusion device delivery system may be initiated. In some embodiments,the occlusion device delivery system may remain within the patient untilthe aneurysm 10 has been occluded greater than about 90%, at whichpoint, withdrawal of the occlusion device delivery system may beinitiated. In some embodiments, the occlusion device delivery system mayremain within the patient until the aneurysm has been occluded greaterthan 80%, at which point, withdrawal of the occlusion device deliverysystem may be initiated. In some embodiments, the occlusion devicedelivery system may remain within the patient until the aneurysm hasbeen occluded greater than about 70%, at which point, withdrawal of theocclusion device delivery system may be initiated. In some embodiments,the occlusion device delivery system may remain within the patient untilthe aneurysm has been occluded greater than about 60%, at which point,withdrawal of the occlusion device delivery system may be initiated. Insome embodiments, the occlusion device delivery system may remain withinthe patient until the aneurysm has been occluded greater than about 50%,at which point, withdrawal of the occlusion device delivery system maybe initiated. Some embodiments provide for initiation of withdrawal ofthe occlusion device delivery system at greater than about 20%, 25%,30%, 35%, 40%, 45%, 50%, 55%, 65%, 75%, 85%, or 95%. Some embodimentsprovide for initiation of withdrawal of the occlusion device deliverysystem at between about 50% and about 100%, between about 50% and about90%, between about 50% and about 80%, between about 50% and about 70%,between about 50% and about 60%, between about 60% and about 100%,between about 60% and about 90%, between about 60% and about 80%,between about 60% and about 70%, between about 70% and about 100%,between about 70% and about 90%, between about 70% and about 80%,between about 80% and about 100%, between about 80% and about 90%,between about 90% and about 100%. In some embodiments, for example whenthe occlusion device comprises a cover or is minimally porous,initiation of withdrawal of the occlusion device delivery system may bedesired at about 100%. For example, some occlusion devices that comprisea small portion that is covered or that is less dense than the rest ofthe occlusion device in order to provide substantially 100% occlusionwhile still allowing perfusion to branch vessels are difficult toposition due to the small size of the covered or denser area and thesmall size of the aneurysm, but methods described herein can provide anoperator with an indication that deployment of such an occlusion devicewas successful. In some embodiments in which the occlusion device isporous, less than 100% occlusion is possible and observation ordetermination of partial stagnation may be used to initiate ofwithdrawal of the occlusion device delivery system.

As it may take some time to remove the occlusion device delivery systemfrom the vessel, the percentage of occlusion or obstruction may haveincreased or decreased between the time withdrawal of the occlusiondevice delivery system was initiated and the time withdrawal of theocclusion device delivery system is complete. In some embodiments, itmay be possible to precisely determine the percentage (e.g., using acomputer imaging system). In some embodiments, a trained physician orother user may be able to determine whether a certain percentage hasbeen achieved (e.g., by comparison to a reference).

It will be appreciated that the percentage area or volume of thestagnated area 77 is not the only portion of the aneurysm in which bloodflow 3 may have stagnated. Rather, the stagnated area 77 may beindicative of a region of the aneurysm 10 in which the contrast agenthas settled, thereby indicating a certain level of stagnation within theentire aneurysm 10 or within portions of the aneurysm 10.

Following deployment of the device, images of the aneurysm 10, or use ofany of the other techniques described herein, may be used to monitor theprogress of the occlusion of the aneurysm 10. If the aneurysm 10 doesnot occlude, it is possible to perform additional therapeutic treatment(e.g., deploy an additional occlusion device, deploy an additionalocclusion device within the original occlusion device, withdraw theoriginal occlusion device and deploy a different occlusion device) toeffect sufficient occlusion of the aneurysm 10. In certain embodimentsin which another occlusion device is deployed, the original occlusiondevice delivery system may be withdrawn, leaving the delivery catheterin place at the treatment site, and another occlusion device deliverysystem comprising the other occlusion device may be delivered to thetreatment site via the catheter. The process may be repeated until theaneurysm 10 is sufficiently occluded.

Upon determining that the aneurysm 10 has been obstructed by a desiredamount after the original or additional therapeutic treatment, theocclusion device delivery system may be removed from the vessel. In someembodiments, the desired amount is based on a comparison of a firstimage of an aneurysm 10 (e.g., before or during deployment of theocclusion device) to a second image of the aneurysm 10 (e.g., during orafter deployment of the occlusion device). In certain such embodiments,comparing the first image to the second image comprises comparing anarea or volume of contrast agent in the aneurysm 10 in the first image(e.g., having the aneurysm 10 full of contrast agent) to an area orvolume of contrast agent in the aneurysm 10 in the second image (e.g.,to determine a percentage of obstruction as described above). In someembodiments, the desired amount is identification of a shape indicativeof statis or stagnation (e.g., a flat surface, an approximatehemisphere, a mushroom, a crescent, any persistent shape, etc.). In someembodiments, the desired amount includes determining whether a branchvessel has been obstructed, in which case the occlusion device mayoptionally be repositioned or removed.

After withdrawal of the occlusion device delivery system, the aneurysm10 may progressively thrombose over the ensuing days to weeks, forexample starting in the stagnated area 77, as described above. Certainartisans may thus characterize the stagnated area 77 as a partialthrombosis 77.

FIGS. 85A-85D illustrate elevational pictures taken via fluoroscopy ofcertain embodiments of treatment of an aneurysm with an occlusion device(e.g., a stent such as described herein). FIG. 85A illustrates contraststasis within the dependent aspect of the aneurysm (e.g., visualized onfluoroscopy through the osseous structures of the skull base). Thecontrast agent stagnated within the aneurysm forms a distinct flatsurface, an approximate hemisphere, and a mushroom. FIG. 85B illustratesreduced contrast opacification. FIG. 85C, which is a subtracted venousphase image, illustrates stasis of contrast agent within the aneurysmpersisting late into the venous phase. FIG. 85D illustrates areconstruction in which two occlusion devices were placed in thesupraclinoid ICA to achieve contrast stasis within the dependent aspectof the aneurysm. The subtracted image of FIG. 85D shows effective flowdiversion with minimal residual filling of the aneurysm.

In some embodiments, a method of implanting a stent at an aneurysm in ablood vessel comprises: providing an elongate body (e.g., a deploymentsystem as described herein) comprising a proximal portion, a distalportion, and a lumen extending between the proximal portion and thedistal portion; inserting the distal portion in a blood vesselcomprising the aneurysm; advancing the distal portion within the bloodvessel until the distal portion is at the aneurysm; advancing, relativeto the elongate body and within the lumen of the elongate body, a stent(e.g., a stent as described herein) in a compressed configuration;expanding the stent within the vessel, the expanded stent extending froma first location distal to the aneurysm to a second location proximal tothe aneurysm (see, e.g., an expanded stent 30 extending from a firstlocation distal to the aneurysm 10 to a second location proximal to theaneurysm 10 in FIGS. 83A-83D and 84A-84E); and following the expandingthe stent and upon determining whether fluid flow in the aneurysm hasstagnated by at least about 50% of an area or a volume of the aneurysmobserved on an image, withdrawing the elongate body from the vessel. Insome embodiments, the stent 30 shown in FIGS. 83A-83D and 84A-84E cancomprise the same type of stent as stent 66 occluding device 100described above, though other stents are also possible.

In some embodiments, a method of at least partially obstructing ananeurysm comprises: advancing a delivery device (e.g., a deploymentdevice as described herein) within a blood vessel until a distal portionof the delivery device is adjacent the aneurysm; expanding a stent(e.g., a stent as described herein) across the aneurysm; imaging theaneurysm (e.g., via fluoroscopy); determining a degree of obstruction ofthe aneurysm after expanding the stent; and after determining that abody of the aneurysm has been obstructed at least about 50%, withdrawingthe delivery device from the vessel.

In some embodiments, a method of treating an aneurysm comprises:advancing a delivery device (e.g., a deployment device as describedherein) within a blood vessel comprising an aneurysm until a distalportion of the device is adjacent the aneurysm; expanding a first stent(e.g., a stent as described herein) within the vessel, the expandedfirst stent extending from a first side of the aneurysm to a second sideof the aneurysm (see, e.g., the expanded first stent 30 extending from afirst side of the aneurysm 10 to a second side of the aneurysm 10 inFIGS. 83A-83D and 84A-84E); and withdrawing the delivery device from thevessel upon determining that the aneurysm is between about 50% and about100% occluded.

In some embodiments, a method of reducing blood flow within an aneurysmcomprises: injecting a contrast agent into a blood vessel comprising ananeurysm; deploying an occlusion device across the aneurysm (see, e.g.,the occlusion device 30 across the aneurysm 10 in FIGS. 83A-83D and84A-84E); producing an image of the aneurysm including the contrastagent (see, e.g., the images shown in FIGS. 83A-85D); and withdrawingthe delivery device from the vessel after observing that the aneurysmhas been obstructed by a desired amount (e.g., a percentage obstruction,a desired shape, etc.).

In some embodiments, a method of reducing blood flow within an aneurysmcomprises: injecting a contrast agent into a blood vessel comprising ananeurysm; deploying an occlusion device across the aneurysm (see, e.g.,the occlusion device 30 across the aneurysm 10 in FIGS. 83A-83D and84A-84E); producing an image of the aneurysm including the contrastagent (see, e.g., the images shown in FIGS. 83A-85D); observing a shapeformed by the contrast agent after deploying the occlusion device; andwithdrawing the delivery device from the vessel after observing that theshape.

In some embodiments, a method of implanting a stent at an aneurysmcomprises: providing an elongate body (e.g., a deployment system asdescribed herein) comprising a proximal portion, a distal portion, and alumen extending between the proximal portion and the distal portion;advancing the elongate body into the patient until the distal portion isadjacent to the aneurysm; delivering the stent across the aneurysm fromwithin the lumen at the distal portion of the elongate body, whereindelivering the stent comprises expanding the stent from a compressedconfiguration to an expanded configuration with a first location distalto the aneurysm and a second location proximal to the aneurysm (see,e.g., the expanded stent 30 extending from a first location distal tothe aneurysm 10 to a second location proximal to the aneurysm 10 inFIGS. 83A-83D and 84A-84E); observing stagnation within the aneurysmcaused by the delivering of the stent across the aneurysm; andwithdrawing the elongate body from the patient with the expanded stentremaining across the aneurysm once the observed stagnation produces apersistent shape in the aneurysm.

Methods for Treating Plaque

Systems and methods for treating particular lumens within the body of apatient are provided below, specifically in the context of treatingplaque build-up in the vasculature. These systems and methods can employsimilar structures (e.g., delivery catheters, delivery devices, stentsetc.) to those described in the methods described above for treatment ofaneurysms. Although the description may be presented in the context ofone or more embodiments, it is understood that such systems and methodscan be used in various lumens of the body and in various ways that wouldbe appreciated by one of ordinary skill in the art. For example, systemsand methods for treating atherosclerosis in a blood vessel and providingembolic protection during treatment are described according toembodiments of the disclosure.

Atherosclerosis is characterized by plaque buildup in a blood vessel(e.g., carotid artery). The plaque may be made up of cholesterol, cellsand other fatty substances. Over time, the plaque can restrict or blockblood flow through the affected blood vessel. If left untreated, aportion of the plaque can break off as plaque debris that travelsdownstream through the blood vessel to smaller blood vessels. The plaquedebris can block blood flow to the smaller blood vessels resulting indeath of tissue receiving blood from the smaller blood vessels. Forexample, blockage of vessels supplying blood to the heart or brain canresult in heart attack or stroke.

Numerous minimally invasive procedures have been developed to treatatherosclerosis in a blood vessel. In one procedure, a catheter with aninflatable balloon is advanced through the blood vessel to an occlusionsite in the blood vessel caused by plaque buildup. The balloon is theninflated to compress the plaque against the inner wall of the bloodvessel, thereby opening up the occluded blood vessel. In anotherprocedure, a catheter with a cutting tool is advanced through the bloodvessel to the occlusion site. The cutting tool is then used to cut awaythe plaque to open up the occluded blood vessel. The catheter mayinclude an aspirator located near the cutting tool to remove plaquedebris caused by cutting away the plaque. After the blood vessel isopened, a stent or other device can be deployed in the blood vessel atthe treatment site to strengthen the wall of the blood vessel andprevent or reduce the likelihood of reclosure.

During treatment of atherosclerosis, plaque debris can be released intothe blood stream and cause embolization. Embolization occurs when thereleased plaque debris travel downstream from the treatment site andblock blood flow to smaller blood vessels. Embolization can result inheart attack, stroke or other ailment depending on the tissue being fedblood by the blocked blood vessels.

To prevent or limit embolization during treatment of atherosclerosis, insome embodiments, a stent is at least partially deployed in the bloodvessel downstream from the treatment site. The partially deployed stentacts as a filter that captures plaque debris released during treatment,preventing or limiting the plaque debris from traveling downstream tosmaller blood vessels. In some embodiments, after treatment, the stentis fully deployed in the blood vessel, including the treatment site, tostrengthen the wall of the blood vessel and prevent or reduce thelikelihood of reclosure.

FIG. 64 illustrates a system 5 for treating atherosclerosis andproviding embolic protection according to embodiments described herein.The system 5 comprises a catheter 8, a guidewire assembly 57 within thecatheter 8, and a stent 66 loaded onto the guidewire assembly 57. FIG.64 shows a cutaway view of the catheter 8 with the guidewire assembly 57within a lumen 9 of the catheter 8. The guidewire assembly 57, which isused to deploy the stent 66 in a blood vessel, is slidable receivedwithin the lumen 9 of the catheter 8.

The catheter 8 comprises an inflatable balloon 40 and one or more lumens56 fluidly coupled to the balloon 40. The lumens 56 extend from theballoon 40 to a proximal portion of the catheter 8 (not shown), whereinflation fluid can be injected into the lumens 56 through a fluidinjection port to inflate the balloon 40 from a deflated state to aninflated state. FIG. 64 shows the balloon 40 in the deflated state. Insome embodiments, the balloon 40 has a tubular shape that expandsradially when inflated. In these embodiments, the lumen 9 carrying theguidewire assembly 57 runs through the balloon 40.

The catheter 8 has a distal opening 18 through which the guidewireassembly 57 can be advanced beyond the distal end 19 of the catheter 8to deploy the stent in a blood vessel. The lumen 56 extends from thedistal opening 18 to a proximal opening (not shown), through which theguidewire assembly 57 can be inserted into the catheter 8, as shown inFIG. 43.

The guidewire assembly 57 may have the same or similar structure as theguidewire assemblies described above. The guidewire assembly 57comprises a delivery guidewire 59 having a flexible distal tip portion61. The delivery guidewire 59 is configured to transmit torque from aproximal portion of the delivery guidewire 59 to the distal portionwhile being flexible so that the delivery guidewire 59 can bend along atortuous path of a blood vessel. The guidewire assembly 57 also includesone or both of a distal retaining member 62 and a proximal retainingmember 26, which are configured to retain the stent 66 therebetween andhold the stent 66 in position on the guidewire assembly 57. The distaland proximal retaining members 62 and 26 may be implemented using thedistal and proximal retaining members illustrated in FIG. 49. Forexample, the distal retaining member 62 may be implemented using thedistal retaining illustrated in FIG. 50 so that the distal end of thestent 66 can be released by rotating the distal retaining member 62 viathe delivery guidewire 59. The guidewire assembly 57 may also comprise asupport coil 70 (shown in FIG. 47) to support the delivery guidewire 59on the delivery guidewire 59 and maintain the stent 66 in a ready todeploy state.

In some embodiments, the stent 66 is a self-expanding stent comprising atubular lattice structure having a compressed state and an expandedstate. The stent 66 includes a distal portion 67 and a proximal portion68. The stent 66 is loaded onto the guidewire assembly 57 in thecompressed state, as shown in FIG. 64. The stent 66 may be maintained inthe compressed state within the catheter 8 by the inner surface 17 ofthe lumen 9 and the retaining members 62 and 26. The stent 66 isconfigured to automatically expand radially from the compressed state tothe expanded stated when deployed in a blood vessel, as discussed infurther detail below.

A procedure for treating atherosclerosis and preventing, reducing, orlimiting embolization from the treatment is described below withreference to FIGS. 65-69 according to an embodiment of the disclosure.The procedure may be performed using the system 5 illustrated in FIG.64.

Referring to FIG. 65, the catheter 8 is percutaneously introduced into ablood vessel 69 and advanced to a treatment site 53 in the blood vessel69. The treatment site 53 may be characterized by a narrowing (stenotic)of the blood vessel 53 caused by plaque buildup due to atherosclerosis.The blood vessel 69 may be the carotid artery or other artery. In oneembodiment, the stenotic region 54 at the treatment site 53 is treatedusing balloon angioplasty and stenting. Other forms of angioplasty mayalso be used.

The catheter 8 may guided to the treatment site 53 using fluoroscopicimaging, in which one or more radio-opaque markers (not shown) areplaced on the distal portion of the catheter 8 to indicate a position ofthe catheter 8 in a fluoroscopic image. The catheter 8 may also beguided using other imaging techniques including ultrasound and magneticresonance imaging. In one embodiment, the catheter 8 is positioned sothat the balloon 40 of the catheter 8 is positioned within the stenoticregion 54. At this stage, the balloon 40 is in the deflated state, asshown in FIG. 65.

After the catheter 8 is positioned at the treatment site 53, theguidewire assembly 57 is advanced through the distal opening 18 of thecatheter 8. A distal portion 67 of the stent 66 is advanced beyond thedistal end 19 of the catheter 8 while a proximal portion 68 of the stent66 remains within the lumen 9 of the catheter 8. The distal portion ofthe stent 66 is positioned downstream or distally from the stenoticregion 54. The direction of blood flow through the blood vessel isindicated by the arrows in FIG. 65.

Referring to FIG. 66, the distal end of the stent 66 is released,allowing the distal portion 67 of the stent 66 to self expand. This maybe done, for example, by rotating the distal retaining member 62 orother mechanism. A portion of the distal portion 67 of the stent 66contacts the vessel wall 55 in the expanded state. The proximal portionof the 68 within the catheter 8 remains in the compressed state. In thisconfiguration, the distal portion 67 of the stent 66 forms a filterbetween the vessel wall 55 and the distal end 19 of the catheter 8 forcapturing plaque debris.

Pores in the lattice structure of the stent 66 allow blood to flowthrough the distal portion 67 of the stent 66 while capturing plaquedebris. Thus, the stent 66 is partially deployed in the blood vessel 69to act as a filter for preventing or limiting embolization whileallowing blood flow. In some embodiments, the porosity of the filterformed by the distal portion 67 of the stent 66 can be adjusted afterthe distal portion 67 is deployed. For example, the distal portion 67 ofthe stent 66 may be compressed longitudinally to increase the latticedensity and hence decrease the porosity of the distal portion 67 of thestent 66. This may be done to filter smaller plaque debris. In anotherexample, the distal portion 67 of the stent 66 may be expandedlongitudinally to decrease the lattice density and hence increase theporosity of the distal portion 67 of the stent 66. This may be done toallow greater blood flow through the filter. FIG. 36B shows examples ofaxial compression and axial expansion of a stent to adjust porosity ofthe stent.

The distal portion 67 of the catheter 8 may be compressed longitudinallyby advancing the distal end 18 of the catheter 8 after the distalportion 67 is deployed in the blood vessel 69. Advancement of thecatheter 8 causes the distal end 19 of the catheter 8 to engage andapply a compressive force on the distal portion 67 in the axialdirection. Alternatively, the distal portion 67 of the stent 66 may becompressed longitudinally by advancing the guidewire assembly 57 afterthe distal portion 67 is deployed in the blood vessel 67. Advancement ofthe guidewire assembly 57 causes the proximal retaining member 26 toapply a compressive force on the stent 66 in the axial direction. Inboth implementations, contact between the distal portion 67 of the stent66 and the vessel wall 55 holds the stent 66 in place during axialcompression.

The stent 66 may be partially deployed in the blood vessel 69 to formthe filter using other techniques. For example, the distal end 19 of thecatheter 8 may be advanced to a position in the blood vessel 69 distalfrom the stenotic region 54. The catheter 8 may then be retractedrelative to the guidewire assembly 57 to uncover the distal portion 67of the stent 66. In this example, the stent 66 may be retained in thecompressed state by the lumen 9 of the catheter so that the distalportion 67 of the stent 66 automatically expands when the catheter 8 isretracted. In another example, a pusher 50 that engages the proximal endof the stent 66 (shown in FIG. 5) may be used to partially deploy thestent 66 by pushing the distal portion 67 of the stent 66 out of thedistal opening 18 of the catheter 8.

Referring to FIG. 67, the balloon 40 is expanded radially to theexpanded state by the injection of fluid into the balloon 40 through thelumens 56 (shown in FIG. 64). The expansion of the balloon 40 causes theballoon 40 to compresses the plaque in the stenotic region 54 againstthe vessel wall 55, thereby increasing the diameter of the blood vessel69 in the stenotic region 54. During treatment, the distal portion 67 ofthe stent 66 captures plaque debris 58 released from the treatment. Thecapture of the plaque debris 58 limits the plaque debris from travelingdownstream to smaller blood vessels and blocking blood to the smallerblood vessels.

Referring to FIG. 68, the balloon 40 is deflated to the deflated stateafter the diameter of the blood vessel is increased. The plaque debris58 released from the treatment are trapped in the distal portion 67 ofthe stent 66.

Referring to FIG. 69, the catheter 8 is retracted relative to the stent66 to fully deploy the stent 66 in the blood vessel 69, including thestenotic region 54. The rest of the stent 66 expands radially contactingthe vessel wall 55. As shown in FIG. 69, the proximal end of the stent66 extends to a location proximal to the stenotic region 54. After thestent 66 is fully deployed in the blood vessel 69, the catheter 8 andguidewire assembly 57 are withdrawn from the blood vessel 69. The plaquedebris 58 and the remaining plaque in the stenotic region 54 are trappedbetween the stent 66 in the expanded state and the vessel wall 55. Thestent 66 provides structural support to the vessel wall to strengthenthe blood vessel 69 and prevent or reduce the likelihood of reclosure.

The atherosclerosis may be treated using other techniques, in which thedistal portion of the stent 66 is deployed to provide embolicprotection. For example, the plaque in the stenotic region 54 may beremoved using a cutting tool mounted on the catheter 8, a laser beamemitted from a distal portion of the catheter 8, high energy signalemitted from one or more transducers or electrodes disposed on thecatheter 8 and other techniques. For the example of a laser beam, thecatheter may include an optical fiber for transporting the laser beamfrom a laser source to the distal portion of the catheter. In each ofthe these example techniques, the distal portion 67 of the stent 66 canbe deployed as shown in FIG. 66 to capture plaque debris from thetreatment.

FIG. 70 shows the catheter 8 with a cutting tool 73 for treatingatherosclerosis instead of an angioplasty balloon according to someembodiments. In these embodiments, the cutting tool 73 is mounted on theouter surface of the catheter 8. FIG. 71 shows the cutting tool 73comprising cutting blades orientated at an angle on the outer surface ofthe catheter 8. In these embodiments, the cutting tool 73 can be used tocut away plaque by rotating the cutting tool 73 while advancing thecatheter 8 through the stenotic region 54. The cutting tool 73 may berotated by rotating the catheter 8. The cutting tool 73 may have anyshape capable of cutting away plaque. In addition, the cutting tool mayhave an abrasive surface.

In some embodiments, the cutting tool 73 comprises blades that arehinged to the catheter 8. This allows the blades to be folded downwardalong the circumference of the catheter 8 to more easily advance thecatheter 8 through the blood vessel. The blades may be deployed byrotating the catheter 8 in one direction such that the centrifugal forceof the rotation causes the blades to unfold. Additionally, theresistance of the fluid in which the blades are rotating can cause theblades to be deployed. The hinges may be configured so that the bladesare orientated radially from the circumference of the catheter 8 whendeployed. After plaque is removed, the catheter 8 may stop rotating orrotate in an opposite direction so that the blades fold back along thecircumference of the catheter 8.

The catheter 8 may also include one or more aspiration lumens 71 andaspiration ports 74 for removing plaque debris released duringtreatment. In these embodiments, the distal portion 67 of the stent 66may be deployed to capture plaque debris that is not removed through theaspiration ports 74.

A procedure for treating atherosclerosis and preventing or limitingembolization using the catheter 8 in FIGS. 70 and 71 is described belowwith reference to FIG. 72.

The catheter 8 is percutaneously introduced into a blood vessel 69 andadvanced to the treatment site 53 in the blood vessel 69 with thecutting tool 73 located proximal to the stenotic region 54. In oneembodiment, the catheter 8 is advanced to the treatment 53 through anouter catheter or sheath 72 in the blood vessel 69 to protect the bloodvessel 69 from the cutting tool 73.

After the catheter 8 is positioned at the treatment site 53, theguidewire assembly 57 is advanced through the distal opening 18 of thecatheter 8. The distal portion 67 of the stent 66 on the guidewireassembly 57 is advanced beyond the distal end 19 of the catheter 8 anddeployed in the blood vessel 69, for example, by rotating the distalretaining member 62. The distal portion 67 of the stent forms a filterbetween the vessel wall 55 and the catheter 8 to capture plaque debris,as shown in FIG. 72. The resulting filter is located downstream ordistal from the stenotic region 54.

After the distal portion 67 of the stent 66 is deployed, the cutting 73can be used to cut away the plaque in the stenotic region 54. In oneembodiment, the cutting tool 73 can be rotated and advanced through thestenotic region 54 to cut away plaque. In this embodiment, the stent 66may be deployed with a large enough portion of the distal portion 67contacting the vessel wall 55 so that a portion of the distal portion 67still contacts the vessel wall 55 after the cutting tool 73 has beenadvanced through the stenotic region 54. After plaque has been cut awayin the stenotic region 54, the catheter 8 can be withdrawn relative tothe stent 66 to fully deploy the stent 66 in the blood vessel 69, asshown in FIG. 69.

FIG. 73 shows a catheter 8 with a cutting device 132 slidably receivedwithin a working lumen 129 of the catheter 8 according to someembodiments. In these embodiments, the cutting device 132 comprises acutting tool 135 mounted on the distal tip 133 of a flexible drive shaft131. The cutting tool 135 may comprise blades, an abrasive surfaceand/or a combination of both. To cut away plaque in a blood vessel, thecutting device 132 is advanced out of the catheter 8 through an opening137. The opening 137 is positioned near the distal end 19 of thecatheter 8.

FIG. 74 illustrates a procedure for treating atherosclerosis andpreventing or limiting embolization using the cutting device 132according to some embodiments. The catheter 8 is positioned at thestenotic region 54 and the distal portion 67 of the stent 66 is deployedin the blood vessel 69 to form a filter for trapping plaque debris. Thecutting device 132 is then advanced through the opening 137 of thecatheter 8 toward the plaque of the stenotic region 54. To cut awayplaque, the drive shaft 131 rotates the cutting tool 135 and advancesthe cutting tool 135 through the stenotic region 54 as the cutting tool135 rotates. The catheter 8 may also rotate slowly so that the cuttingtool 135 can cut away plaque along the circumference of the blood vessel69. As an alternative to rotating the cutting tool 135, the drive shaft131 can move the cutting tool 135 back and forth to cut away plaque. Inthis example, the cutting tool 135 may comprise a plurality of bladesdisposed along the circumference of the distal top 133 and/or anabrasive surface.

After plaque has been cut away in the stenotic region 54, the cuttingtool 135 can be withdrawn back into the catheter 8. The catheter 8 canthen be withdrawn relative to the stent 66 to fully deploy the stent 66in the blood vessel 69, as shown in FIG. 69.

The cutting device 132 may also be advanced into the blood vessel 69separately from the catheter 8 instead of through the working lumen 129of the catheter 8. FIG. 75 shows an example in which the cutting device132 and the catheter 8 are advanced separately to the stenotic region 54through an outer catheter or sheath 72 in the blood vessel 69. To cutaway plaque, the drive shaft 131 may rotate the cutting tool 135 whileadvancing the cutting tool 135 through the stenotic region 54 and/ormove the cutting tool 135 back and forth in the stenotic region 54. Thecutting tool 135 may be moved around the catheter 8 to cut away plaquealong the circumference of the blood vessel 69.

FIG. 76 shows a cutting tool 140 disposed on a catheter or sheath 142separate from the catheter 8 used to deploy the stent 66 according tosome embodiments. In these embodiments, the catheter 142 is advancedover the catheter 8 to the stenotic region 54. The catheter 142 includesa lumen (not shown) for receiving the catheter 8 therein as the catheter142 is advanced over the catheter 8.

FIG. 76 illustrates a procedure for treating atherosclerosis andpreventing or limiting embolization using the cutting device 132according to some embodiments. The catheter 8 is positioned at thestenotic region 54 and the distal portion 67 of the stent 66 is deployedin the blood vessel 69 to form a filter for trapping plaque debris. Thecatheter 142 is advanced over the catheter 8 toward the plaque of thestenotic region 54. To cut away plaque, the cutting tool 140 may berotated by rotating the catheter 142 over the catheter 8. The rotatingcutting tool 104 may then be advanced through the stenotic region 54 byadvancing the catheter 142 over the catheter 8 as the catheter 142rotates. Alternatively, the cutting tool 140 may be moved back and forthin the stenotic region 54 to cut away plaque by moving the catheter 142back and forth.

After plaque has been cut away in the stenotic region 54, the catheter142 be can withdrawn through the outer catheter 72. The catheter 8 canthen be withdrawn relative to the stent 66 to fully deploy the stent 66in the blood vessel 69, as shown in FIG. 69.

In some embodiments, the cutting tool 140 comprises a blade wrappedalong the circumference of the catheter 142 with a sharp edge facingdistally. In these embodiments, the blade can cut away plaque around thecircumference of the catheter 142 by advancing the catheter 142 throughthe stenotic region 54.

Referring to FIG. 77, in some embodiments, the stent 66 is deployed inthe stenotic region 54 and in a region of the blood vessel 69 distal tothe stenotic region 54 to prevent or limit embolization, as discussedbelow. The stent 66 may be deployed in the blood vessel 69 using theguidewire assembly 57 or other mechanism. FIG. 77 shows across-sectional view of the stent 66 in order to show devices positionedwithin the inner lumen of the stent 66. The deployed stent 66 contactsthe vessel wall 55 in the region of the blood vessel 69 distal to thestenotic region 54 and plaque in the stenotic region 54. In theseembodiments, the atherosclerosis may be treated using the catheter 8shown in FIG. 64 or other catheter.

In some embodiments, after the stent 66 is deployed, the balloon 40 ofthe catheter 8 is positioned within the stent 66 in the stenotic region54 (shown in FIG. 78). The balloon 40 is then expanded radially to theexpanded state by the injection of fluid into the balloon 40 through thelumens 56 (shown in FIG. 79). The expansion of the balloon 40 causes theballoon 40 to press radially against the inner surface of the stent 66.This in turn causes the stent 66 to compresses the plaque in thestenotic region 54 against the vessel wall 55, thereby increasing thediameter of the blood vessel 69 in the stenotic region 54. The portionof the stent 66 deployed distally from the stenotic region 54facilitates the capture of plaque debris between the vessel wall 55 andthe stent 66, thereby preventing or limiting embolization.

After the stenotic region 54 is opened, the balloon 40 is deflated tothe deflated state and the catheter 8 is withdrawn from the blood vessel69. The plaque remain trapped between the vessel wall 55 and the stent66.

The balloon 40 may be disposed on the guidewire assembly 57 instead ofthe catheter 8. FIG. 80 shows the balloon 40 disposed on the guidewireassembly 57 according to some embodiments. The balloon 40 is locatedproximal to the proximal retaining member 26. The guidewire assembly 57includes one or more lumens (not shown) fluidly coupled to the balloon40 for injecting inflation fluid into the balloon 40 to radially expandthe balloon 40 from the deflated state (shown in FIG. 80) to theinflated stated.

To treat atherosclerosis, the stent 66 is deployed in the stenoticregion 54 and in a region of the blood vessel 69 distal to the stenoticregion 54 to prevent or limit embolization, as discussed below. Thestent 66 may be deployed in the blood vessel 69 using the guidewireassembly 57 (shown in FIG. 81) or other mechanism. FIG. 81 shows across-sectional view of the stent 66 in order to show devices positionedwithin the inner lumen stent 66.

In some embodiments, after the stent 66 is deployed, the balloon 40 ofthe guidewire assembly 40 is positioned within the stent 66 in thestenotic region 54 (shown in FIG. 81). The balloon 40 is then expandedradially to the expanded state by the injection of fluid into theballoon 40 (shown in FIG. 82). The expansion of the balloon 40 causesthe balloon 40 to press radially against the inner surface of the stent66. This in turn causes the stent 66 to compresses the plaque in thestenotic region 54 against the vessel wall 55, thereby increasing thediameter of the blood vessel 69 in the stenotic region 54. The portionof the stent 66 deployed distally from the stenotic region 54facilitates the capture of plaque debris between the vessel wall 55 andthe stent 66, thereby preventing or limiting embolization.

After the stenotic region 54 is opened, the balloon 40 is deflated tothe deflated state and the guidewire assembly 57 and the catheter 8 arewithdrawn from the blood vessel. The plaque remains trapped between thevessel wall 55 and the stent 66.

In some embodiments, the expansive force of the stent 66 when deployedin the stenotic region 54 is sufficient to open the stenotic region 54.In these embodiments, the distal portion 67 of the stent 66 may bedeployed in a region of the blood vessel 69 distal to the stenoticregion 64. A portion of the stent 66 proximal to the distal portion 67may then be deployed in the stenotic region 54. As the stent 66 expandsradially in the stenotic region 54 during deployment, the expansiveforce of the stent 66 presses the plaque in the stenotic region 54against the vessel wall 55, thereby increasing the diameter of the bloodvessel in the stenotic region. Plaque is trapped between the vessel wall55 and the stent 66. The portion of the stent 66 deployed distally fromthe stenotic region 54 facilitates the capture of plaque debris betweenthe vessel wall 55 and the stent 66, thereby preventing or limitingembolization.

After the stent 66 is deployed in the blood vessel 69, plaque in thestenotic region 54 and plaque debris remain trapped between the vesselwall 55 and the stent 66. Overtime, neointima can build up over theinner surface of the stent 66. As a result, a new inner lining of theblood vessel 69 is formed over the inner surface of the stent 66, whichfacilitates the retention of plaque and plaque debris between the oldinner lining of the blood vessel 69 and the stent 66.

Examples of Particular Lumens

In some embodiments, “occluding device” and “stent” as used herein areused interchangeably. In some embodiments, “cell” and “pore” as usedherein are used interchangeably. In some embodiments, porosity refers toa value inversely proportional to lattice density.

The apparatus and methods discussed herein are not limited to thedeployment and use of an occluding device within any particular vessels,but may include any number of different types of vessels. For example,in some aspects, vessels may include arteries or veins. In some aspects,the vessels may be suprathoracic vessels (e.g., vessels in the neck orabove), intrathoracic vessels (e.g., vessels in the thorax), subthoracicvessels (e.g., vessels in the abdominal area or below), lateral thoracicvessels (e.g., vessels to the sides of the thorax such as vessels in theshoulder area and beyond), or other types of vessels and/or branchesthereof.

In some aspects, the suprathoracic vessels may comprise at least one ofintracranial vessels, cerebral arteries, and/or any branches thereof.For example, the suprathoracic vessels may comprise at least one of acommon carotid artery, an internal carotid artery, an external carotidartery, a middle meningeal artery, superficial temporal arteries, anoccipital artery, a lacrimal (ophthalmic) artery, an accessory meningealartery, an anterior ethmoidal artery, a posterior ethmoidal artery, amaxillary artery, a posterior auricular artery, an ascending pharyngealartery, a vertebral artery, a left middle meningeal artery, a posteriorcerebral artery, a superior cerebellar artery, a basilar artery, a leftinternal acoustic (labyrinthine) artery, an anterior inferior cerebellarartery, a left ascending pharyngeal artery, a posterior inferiorcerebellar artery, a deep cervical artery, a highest intercostal artery,a costocervical trunk, a subclavian artery, a middle cerebral artery, ananterior cerebral artery, an anterior communicating artery, anophthalmic artery, a posterior communicating artery, a facial artery, alingual artery, a superior laryngeal artery, a superior thyroid artery,an ascending cervical artery, an inferior thyroid artery, athyrocervical trunk, an internal thoracic artery, and/or any branchesthereof. The suprathoracic vessels may also comprise at least one of amedial orbitofrontal artery, a recurrent artery (of Heubner), medial andlateral lenticulostriate arteries, a lateral orbitofrontal artery, anascending frontal (candelabra) artery, an anterior choroidal artery,pontine arteries, an internal acoustic (labyrinthine) artery, ananterior spinal artery, a posterior spinal artery, a posterior medialchoroidal artery, a posterior lateral choroidal artery, and/or branchesthereof. The suprathoracic vessels may also comprise at least one ofperforating arteries, a hypothalamic artery, lenticulostriate arteries,a superior hypophyseal artery, an inferior hypophyseal artery, ananterior thalamostriate artery, a posterior thalamostriate artery,and/or branches thereof. The suprathoracic vessels may also comprise atleast one of a precentral (pre-Rolandic) and central (Rolandic)arteries, anterior and posterior parietal arteries, an angular artery,temporal arteries (anterior, middle and posterior), a paracentralartery, a pericallosal artery, a callosomarginal artery, a frontopolarartery, a precuneal artery, a parietooccipital artery, a calcarineartery, an inferior vermian artery, and/or branches thereof.

In some aspects, the suprathoracic vessels may also comprise at leastone of diploic veins, an emissary vein, a cerebral vein, a middlemeningeal vein, superficial temporal veins, a frontal diploic vein, ananterior temporal diploic vein, a parietal emissary vein, a posteriortemporal diploic vein, an occipital emissary vein, an occipital diploicvein, a mastoid emissary vein, a superior cerebral vein, efferenthypophyseal veins, infundibulum (pituitary stalk) and long hypophysealportal veins, and/or branches thereof.

The intrathoracic vessels may comprise the aorta or branches thereof.For example, the intrathoracic vessels may comprise at least one of anascending aorta, a descending aorta, an arch of the aorta, and/orbranches thereof. The descending aorta may comprise at least one of athoracic aorta, an abdominal aorta, and/or any branches thereof. Theintrathoracic vessels may also comprise at least one of a subclavianartery, an internal thoracic artery, a pericardiacophrenic artery, aright pulmonary artery, a right coronary artery, a brachiocephalictrunk, a pulmonary trunk, a left pulmonary artery, an anteriorinterventricular artery, and/or branches thereof. The intrathoracicvessels may also comprise at least one of an inferior thyroid artery, athyrocervical trunk, a vertebral artery, a right bronchial artery, asuperior left bronchial artery, an inferior left bronchial artery,aortic esophageal arteries, and/or branches thereof.

In some aspects, the intrathoracic vessels may also comprise at leastone of a right internal jugular vein, a right brachiocephalic vein, asubclavian vein, an internal thoracic vein, a pericardiacophrenic vein,a superior vena cava, a right superior pulmonary vein, a leftbrachiocephalic vein, a left internal jugular vein, a left superiorpulmonary vein, an inferior thyroid vein, an external jugular vein, avertebral vein, a right highest intercostal vein, a 6th rightintercostal vein, an azygos vein, an inferior vena cava, a left highestintercostal vein, an accessory hemiazygos vein, a hemiazygos vein,and/or branches thereof.

In some aspects, the subthoracic vessels may comprise at least one ofrenal arteries, inferior phrenic arteries, a celiac trunk with commonhepatic, left gastric and splenic arteries, superior suprarenalarteries, a middle suprarenal artery, an inferior suprarenal artery, aright renal artery, a subcostal artery, 1st to 4th right lumbararteries, common iliac arteries, an iliolumbar artery, an internal iliacartery, lateral sacral arteries, an external iliac artery, a testicular(ovarian) artery, an ascending branch of deep circumclex iliac artery, asuperficial circumflex iliac artery, an inferior epigastric artery, asuperficial epigastric artery, a femoral artery, a ductus deferens andtesticular artery, a superficial external pudendal artery, a deepexternal pudendal artery, and/or branches thereof. The subthoracicvessels may also comprise at least one of a superior mesenteric artery,a left renal artery, an abdominal aorta, an inferior mesenteric artery,colic arteries, sigmoid arteries, a superior rectal artery, 5th lumbararteries, a middle sacral artery, a superior gluteal artery, umbilicaland superior vesical arteries, an obturator artery, an inferior vesicaland artery to ductus deferens, a middle rectal artery, an internalpudendal artery, an inferior gluteal artery, a cremasteric, pubic(obturator anastomotic) branches of inferior epigastric artery, a leftcolic artery, rectal arteries, and/or branches thereof.

In some aspects, the lateral thoracic vessels may comprise at least oneof humeral arteries, a transverse cervical artery, a suprascapularartery, a dorsal scapular artery, and/or branches thereof. The lateralthoracic vessels may also comprise at least one of an anteriorcircumflex humeral artery, a posterior circumflex humeral artery, asubscapular artery, a circumflex scapular artery, a brachial artery, athoracodorsal artery, a lateral thoracic artery, an inferior thyroidartery, a thyrocervical trunk, a subclavian artery, a superior thoracicartery, a thoracoacromial artery, and/or branches thereof.

In some embodiments, a catheter, such as that described in U.S. patentapplication Ser. No. 12/731,110, which was filed on Mar. 24, 2010 andwhich incorporated herein by reference in its entirety, can be used todeliver an occluding device delivery system. The delivery system caninclude an expandable occluding device (e.g., stent) configured to beplaced across an aneurysm that is delivered through the distal portionof the catheter, out a distal tip, and into the vasculature adjacent ananeurysm in the middle cerebral artery. A proximal portion of thecatheter can remain partially or entirely within a guiding catheterduring delivery, and an intermediate portion, taper portion, and distalportion of the catheter can extend distally of the guiding catheter. Theoccluding device can be released at the target location and can be usedto occlude blood flow into the aneurysm. The catheter can be used toreach target locations (e.g., aneurysms) located elsewhere in the bodyas well, include but not limited to other arteries, branches, and bloodvessels such as those described above.

The apparatus and methods discussed herein are not limited to thedeployment and use of an occluding device within the vascular system butmay include any number of further treatment applications. Othertreatment sites may include areas or regions of the body such as organbodies. Modification of each of the above-described apparatus andmethods for carrying out the subject technology, and variations ofaspects of the disclosure that are apparent to those of skill in the artare intended to be within the scope of the claims. Furthermore, noelement, component or method step is intended to be dedicated to thepublic regardless of whether the element, component or method step isexplicitly recited in the claims.

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the subject technology butmerely as illustrating different examples and aspects of the subjecttechnology. It should be appreciated that the scope of the subjecttechnology includes other embodiments not discussed in detail above.Various other modifications, changes and variations which will beapparent to those skilled in the art may be made in the arrangement,operation and details of the method and apparatus of the subjecttechnology disclosed herein without departing from the spirit and scopeof the subject technology as defined in the appended claims. Therefore,the scope of the subject technology should be determined by the appendedclaims and their legal equivalents. Furthermore, no element, componentor method step is intended to be dedicated to the public regardless ofwhether the element, component or method step is explicitly recited inthe claims. Underlined and/or italicized headings and subheadings areused for convenience only, do not limit the subject technology, and arenot referred to in connection with the interpretation of the descriptionof the subject technology. In the claims and description, unlessotherwise expressed, reference to an element in the singular is notintended to mean “one and only one” unless explicitly stated, but ratheris meant to mean “one or more.” In addition, it is not necessary for adevice or method to address every problem that is solvable by differentembodiments of the disclosure in order to be encompassed by the claims.

What is claimed is:
 1. A method of reducing blood flow within ananeurysm comprising: injecting a contrast agent into a blood vesselcomprising an aneurysm; deploying an occlusion device from a deliverydevice in the blood vessel next to the aneurysm; producing an image ofthe aneurysm including the contrast agent; confirming that the contrastagent forms a shape after deploying the occlusion device; and while thecontrast agent has formed the shape, withdrawing the delivery devicefrom the blood vessel.
 2. The method of claim 1, wherein the shapecomprises a crescent shape, a mushroom shape, a hemispherical shape,and/or a flat side.
 3. The method of claim 1, wherein the shape formedby the contrast agent comprises a stagnated area in the aneurysm.
 4. Themethod of claim 1, wherein after withdrawing the delivery device,substantially all of the aneurysm progressively thromboses.
 5. Themethod of claim 1, wherein the confirming is sufficient to determinethat the deploying the occlusion device is sufficient to lead tothrombosis of the aneurysm.
 6. The method of claim 1, wherein theconfirming comprises comparing a first image of the aneurysm beforedeploying the occlusion device to a second image of the aneurysm afterdeploying the occlusion device.
 7. The method of claim 1, whereindeploying the occlusion device comprises expanding a stent across a neckof the aneurysm.
 8. The method of claim 1, wherein confirming that thecontrast agent forms a shape comprises confirming that the contrastagent forms a persistent shape.
 9. The method of claim 1, furthercomprising observing stagnation within the aneurysm caused by theocclusion device.
 10. A method of implanting a stent at an aneurysmcomprising: providing an elongate body comprising a proximal portion, adistal portion, and a lumen extending between the proximal portion andthe distal portion; advancing the elongate body into a patient until thedistal portion is adjacent to the aneurysm; delivering a stent acrossthe aneurysm from within the lumen at the distal portion of the elongatebody, wherein delivering the stent comprises expanding the stent from acompressed configuration to an expanded configuration with a firstlocation distal to the aneurysm and a second location proximal to theaneurysm; observing stagnation within the aneurysm caused by deliveringthe stent across the aneurysm; and withdrawing the elongate body fromthe patient with the expanded stent remaining across the aneurysm oncethe observed stagnation produces a persistent shape in the aneurysm. 11.The method of claim 10, wherein the persistent shape comprises acrescent shape, a mushroom shape, a hemispherical shape, and/or a flatside.
 12. The method of claim 10, wherein after withdrawing the elongatebody, substantially all of the aneurysm progressively thromboses. 13.The method of claim 10, wherein observing stagnation within the aneurysmcomprises injecting a contrast agent into a blood vessel comprising theaneurysm.
 14. The method of claim 13, wherein observing stagnationwithin the aneurysm comprises producing an image of the aneurysmincluding the contrast agent.
 15. A method of reducing blood flow withinan aneurysm comprising: injecting a contrast agent into a blood vesselcomprising an aneurysm, at least a portion of the contrast agent flowinginto the aneurysm; deploying an occlusion device from a delivery devicein the blood vessel next to the aneurysm; stagnating the portion of thecontrast agent in the aneurysm; producing an image of the aneurysmincluding the portion of the contrast agent; observing a shape formed bythe portion of the contrast agent in the aneurysm after deploying theocclusion device; and withdrawing the delivery device from the bloodvessel after observing the shape.
 16. The method of claim 15, whereinthe shape comprises a crescent shape, a mushroom shape, a hemisphericalshape, and/or a flat side.
 17. The method of claim 15, wherein the shapeformed by the contrast agent comprises a stagnated area in the aneurysm.18. The method of claim 15, wherein after withdrawing the deliverydevice, substantially all of the aneurysm progressively thromboses. 19.The method of claim 15, wherein the delivery device comprises acatheter.
 20. The method of claim 15, wherein the observing issufficient to determine that the deploying the occlusion device issufficient to lead to thrombosis of the aneurysm.
 21. The method ofclaim 15, wherein the observing comprises comparing a first image of theaneurysm before deploying the occlusion device to a second image of theaneurysm after deploying the occlusion device.
 22. The method of claim15, wherein deploying the occlusion device comprises expanding a stentacross a neck of the aneurysm.
 23. The method of claim 15, whereinobserving a shape formed by the portion of the contrast agent in theaneurysm comprises confirming that the contrast agent forms a persistentshape.